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1.  Propofol-Based Sedation Does Not Increase Rate of Complication during Percutaneous Endoscopic Gastrostomy Procedure 
Objectives. To evaluate and compare the complication rate of sedation with or without propofol regimen for percutaneous endoscopic gastrostomy (PEG) in a hospital in Thailand. Subjects and Methods. A total of 198 patients underwent PEG procedures by using intravenous sedation (IVS) from Siriraj Hospital, Thailand from August 2006 to January 2009. The primary outcome variable was the overall complication rate. The secondary outcome variables were sedation and procedure related complications, and mortality rate. Results. After matching ASA physical status and indications of procedure, there were 92 PEG procedures in propofol based sedation group (A) and 20 PEG procedures in non-propofol based sedation group (B). All sedation was given by residents or anesthetic nurses directly supervised by staff anesthesiologist in the endoscopy room. There were no significant differences in patients' characteristics, sedation time, indication, complications, anesthetic personnel and mortality rate between the two groups. All complications were easily treated, with no adverse sequelae. Mean dose of fentanyl and midazolam in group A was significantly lower than in group B. Conclusion. Propofol-based sedation does not increase rate of complication during PEG procedure. Additionally, IVS of PEG procedure is relatively safe and effective when performed by physicians in training. Serious complications are none.
doi:10.1155/2011/134819
PMCID: PMC2929499  PMID: 20811547
2.  Age-dependent safety analysis of propofol-based deep sedation for ERCP and EUS procedures at an endoscopy training center in a developing country 
Introduction
Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasonography (EUS) procedures in elderly patients are on the rise, and they play an important role in the diagnosis and management of various gastrointestinal diseases. The use of deep sedation in these patients has been established as a safe and effective technique in Western countries; however, it is uncertain if the situation holds true among Asians. The present study aimed to evaluate the age-dependent safety analysis and clinical efficacy of propofol-based deep sedation (PBDS) for ERCP and EUS procedures in adult patients at a World Gastroenterology Organization (WGO) Endoscopy Training Center in Thailand.
Methods
We undertook a retrospective review of anesthesia or sedation service records of patients who underwent ERCP and EUS procedures. All procedures were performed by staff endoscopists, and all sedations were administered by anesthesia personnel in the endoscopy room.
Results
PBDS was provided for 491 ERCP and EUS procedures. Of these, 252 patients (mean age, 45.1 + 11.1 years, range 17–65 years) were in the <65 age group, 209 patients (mean age, 71.7 + 4.3 years, range 65–80 years) were in the 65–80 year-old group, and 30 patients (mean age, 84.6 + 4.2 years, range 81–97 years) were in the >80 age group. Common indications for the procedures were pancreatic tumor, cholelithiasis, and gastric tumor. Fentanyl, propofol, and midazolam were the most common sedative drugs used in all three groups. The mean doses of propofol and midazolam in the very old patients were relatively lower than in the other groups. The combination of propofol, midazolam, and fentanyl, as well as propofol and fentanyl, were frequently used in all patients. Sedation-related adverse events and procedure-related complications were not statistically significantly different among the three groups. Hypotension was the most common complication.
Conclusion
In the setting of the WGO Endoscopy Training Center in a developing country, PBDS for ERCP and EUS procedures in elderly patients by trained anesthesia personnel with appropriate monitoring is relatively safe and effective. Although adverse cardiovascular events, including hypotension, in this aged group is common, all adverse events were usually transient, mild, and easily treated, with no sequelae.
doi:10.2147/CEG.S31275
PMCID: PMC3401056  PMID: 22826640
deep sedation; propofol; endoscopic retrograde cholangiopancreatography; endoscopic ultrasonography; elderly; developing country
3.  Propofol versus Midazolam for Sedation during Esophagogastroduodenoscopy in Children 
Clinical Endoscopy  2013;46(4):368-372.
Background/Aims
To evaluate the efficacy and safety of propofol and midazolam for sedation during esophagogastroduodenoscopy (EGD) in children.
Methods
We retrospectively reviewed the hospital records of 62 children who underwent ambulatory diagnostic EGD during 1-year period. Data were collected from 34 consecutive patients receiving propofol alone. Twenty-eight consecutive patients who received sedation with midazolam served as a comparison group. Outcome variables were length of procedure, time to recovery and need for additional supportive measures.
Results
There were no statistically significant differences between the two groups in age, weight, sex, and the length of endoscopic procedure. The recovery time from sedation was markedly shorter in propofol group (30±16.41 minutes) compared with midazolam group (58.89±17.32 minutes; p<0.0001). During and after the procedure the mean heart rate was increased in midazolam group (133.04±19.92 and 97.82±16.7) compared with propofol group (110.26±20.14 and 83.26±12.33; p<0.0001). There was no localized pain during sedative administration in midazolam group, though six patients had localized pain during administration of propofol (p<0.028). There was no serious major complication associated with any of the 62 procedures.
Conclusions
Intravenous administered propofol provides faster recovery time and similarly safe sedation compared with midazolam in pediatric patients undergoing upper gastrointestinal endoscopy.
doi:10.5946/ce.2013.46.4.368
PMCID: PMC3746141  PMID: 23964333
Propofol; Midazolam; Endoscopy, digestive system; Child
4.  Bispectral index monitoring as an adjunct to nurse-administered combined sedation during endoscopic retrograde cholangiopancreatography 
AIM: To determine whether bispectral index (BIS) monitoring is useful for propofol administration for deep sedation during endoscopic retrograde cholangiopancreatography (ERCP).
METHODS: Fifty-nine consecutive patients with a variety of reasons for ERCP who underwent the procedure at least twice between 1 July 2010 and 30 November 2010. This was a randomized cross-over study, in which each patient underwent ERCP twice, once with BIS monitoring and once with control monitoring. Whether BIS monitoring was done during the first or second ERCP procedure was random. Patients were intermittently administered a mixed regimen including midazolam, pethidine, and propofol by trained nurses. The nurse used a routine practice to monitor sedation using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale or the BIS monitoring. The total amount of midazolam and propofol used and serious side effects were compared between the BIS and control groups.
RESULTS: The mean total propofol dose administered was 53.1 ± 32.2 mg in the BIS group and 54.9 ± 30.8 mg in the control group (P = 0.673). The individual propofol dose received per minute during the ERCP procedure was 2.90 ± 1.83 mg/min in the BIS group and 3.44 ± 2.04 mg in the control group (P = 0.103). The median value of the MOAA/S score during the maintenance phase of sedation was comparable for the two groups. The mean BIS values throughout the procedure (from insertion to removal of the endoscope) were 76.5 ± 8.7 for all 59 patients in using the BIS monitor. No significant differences in the frequency of < 80% oxygen saturation, hypotension (< 80 mmHg), or bradycardia (< 50 beats/min) were observed between the two study groups. Four cases of poor cooperation occurred, in which the procedure should be stopped to add the propofol dose. After adding the propofol, the procedure could be conducted successfully (one case in the BIS group, three cases in the control group). The endoscopist rated patient sedation as excellent for all patients in both groups. All patients in both groups rated their level of satisfaction as high (no discomfort). During the post-procedural follow-up in the recovery area, no cases of clinically significant hypoxic episodes were recorded in either group. No other postoperative side effects related to sedation were observed in either group.
CONCLUSION: BIS monitoring trend to slighlty reduce the mean propofol dose. Nurse-administered propofol sedation under the supervision of a gastroenterologist may be considered an alternative under anesthesiologist.
doi:10.3748/wjg.v18.i43.6284
PMCID: PMC3501778  PMID: 23180950
Conscious sedation; Bispectral index monitors; Pancreatic neoplasm; Endoscopic retrograde cholangiopancreatography
5.  Ketamine and midazolam sedation for pediatric gastrointestinal endoscopy in the Arab world 
AIM: To evaluate the safety and effectiveness of intravenous ketamine-midazolam sedation during pediatric endoscopy in the Arab world.
METHODS: A retrospective cohort study of all pediatric endoscopic procedures performed between 2002-2008 at the shared endoscopy suite of King Abdullah University Hospital, Jordan University of Science & Technology, Jordan was conducted. All children were > 1 year old and weighed > 10 kg with American Society of Anesthesiologists class 1 or 2. Analysis was performed in terms of sedation-related complications (desaturation, respiratory distress, apnea, bradycardia, cardiac arrest, emergence reactions), adequacy of sedation, need for sedation reversal, or failure to complete the procedure.
RESULTS: A total of 301 patients (including 160 males) with a mean age of 9.26 years (range, 1-18 years) were included. All were premedicated with atropine; and 79.4% (239/301) had effective and uneventful sedation. And 248 (82.4%) of the 301 patients received a mean dose of 0.16 mg/kg (range, 0.07-0.39) midazolam and 1.06 mg/kg (range, 0.31-2.67) ketamine, respectively within the recommended dosage guidelines. Recommended maximum midazolam dose was exceeded in 17.6% patients [34 female (F):19 male (M), P = 0.003] and ketamine in 2.7% (3 M:5 F). Maximum midazolam dose was more likely to be exceeded than ketamine (P < 0.001). Desaturation occurred in 37 (12.3%) patients, and was reversible by supplemental oxygen in all except 4 who continue to have desaturation despite supplemental oxygen. Four (1.3%) patients had respiratory distress and 6 (2%) were difficult to sedate and required a 3rd sedative; 12 (4%) required reversal and 7 (2.3%) failed to complete the procedure. None developed apnea, bradycardia, arrest, or emergence reactions.
CONCLUSION: Ketamine-midazolam sedation appears safe and effective for diagnostic pediatric gastrointestinal endoscopy in the Arab world for children aged > 1 year and weighing > 10 kg without co-morbidities.
doi:10.3748/wjg.v17.i31.3630
PMCID: PMC3180020  PMID: 21987610
Pediatric endoscopy; Sedation; Ketamine; Arab
6.  Prophylactic Endotracheal Intubation in Critically Ill Patients Undergoing Endoscopy for Upper Gastrointestinal Hemorrhage 
Gastrointestinal endoscopy  2009;69(7):e55-e59.
Background
Cardiopulmonary complications are common after endoscopy for upper gastrointestinal (UGI) hemorrhage in the intensive care unit (ICU)
Objective
To evaluate the practice and outcome of elective prophylactic endotracheal intubation prior to endoscopy for UGI hemorrhage in the ICU
Design
Retrospective, propensity matched case-control study
Setting
A 24-bed medical ICU in a tertiary center.
Patients
ICU patients who underwent endoscopy for UGI hemorrhage
Main Outcome Measurements
Cardiopulmonary complications, ICU and hospital length of stay and mortality. In a propensity analysis, patients who were intubated for airway protection prior to UGI endoscopy were matched by probability of intubation to controls not intubated prior to UGI endoscopy.
Results
Fifty-three out of 307 patients underwent elective prophylactic intubation prior to UGI endoscopy. Probability of intubation depended on APACHE III score (OR 1.4, 95%, CI 1.2 to 1.6), age (OR 0.97, 95%CI 0.95 to 0.09), presence of hematemesis (OR 1.9, 95%CI 0.8 to 5.1), prior lung disease (OR 2.1, 95%CI 0.8 to 4.9) and number of transfusions (OR 1.1 95%CI 1.0 to 1.1 per unit). Non-intubated matched controls were identified for all but 4 patients with active massive hematemesis who were excluded from matched analysis. Cumulative incidence of cardiopulmonary complications (53% vs 45%, p=0.414), ICU (median 2.2 days vs. 1.8 days, p=0.138) and hospital length of stay (6.9 vs. 5.9, p=0.785), and hospital mortality (14% vs. 20%, p=0.366) were similar.
Conclusions
Cardiopulmonary complications are frequent after endoscopy for acute UGI bleeding in ICU patients, and are largely unaffected by the practice of prophylactic intubation.
doi:10.1016/j.gie.2009.03.002
PMCID: PMC2737482  PMID: 19481643
endotracheal intubation; upper gastrointestinal hemorrhage; cardiopulmonary complications; airway protection; esophagogastroduodenoscopy
7.  Addition of sub-anaesthetic dose of ketamine reduces gag reflex during propofol based sedation for upper gastrointestinal endoscopy: A prospective randomised double-blind study 
Indian Journal of Anaesthesia  2014;58(4):436-441.
Background and Aims:
Gag reflex is unwanted during upper gastrointestinal endoscopy (UGIE). Experimental studies have demonstrated that N-methyl-D-aspartate receptor antagonism prevents gag reflex. We conducted a study to determine if sub-anaesthetic doses of ketamine, added to propofol, reduce the incidence of gag reflex.
Methods:
This prospective, randomised, double-blind and placebo-controlled study was done in a tertiary care hospital. A total of 270 patients undergoing UGIE, were randomised to propofol (P) group (n = 135) or propofol plus ketamine (PK) group (n = 135). All patients received propofol boluses titrated to Ramsay sedation score of not <4. Patients in PK group in addition received ketamine, 0.15 mg/kg immediately before the first-propofol dose. Top-up doses of propofol were given as required. Stata 11 software (StataCorp.) was used to calculate the proportion of patients with gag reflex and the corresponding relative risk. Propofol consumed and time to recovery in the two groups was compared using Student's t-test and Cox proportional hazards regression respectively.
Results:
Significantly, fewer patients in the PK group had gag reflex compared to the P group (3 vs. 23, risk ratio = 0.214, 95% confidence interval [CI], 0.07-0.62; P = 0.005). The incidence of hypotension (6 vs. 16, risk ratio = 0.519, 95% CI = 0.25-1.038; P = 0.06), number of required airway manoeuvres (4 vs. 19, risk ratio = 0.32, 95% CI = 0.13-0.74; P = 0.014), median time to recovery (4 min vs. 5 min, hazard ratio = 1.311, 95% CI = 1.029-1.671; P = 0.028) and propofol dose administered (152 mg vs. 167 mg, 95% CI = 4.74-24.55; P = 0.004) was also less in the PK group compared to the P group.
Conclusion:
Ketamine in sub-anaesthetic dose decreases gag reflex during UGIE.
doi:10.4103/0019-5049.138981
PMCID: PMC4155289  PMID: 25197112
Endoscopy; gag reflex; ketamine
8.  Deep sedation for endoscopic retrograde cholangiopancreatography: a comparison between clinical assessment and NarcotrendTM monitoring 
Introduction
Moderate to deep sedation is generally used for endoscopic retrograde cholangiopancreatography (ERCP). The depth of sedation is usually judged by clinical assessment and electroencephalography-guided monitoring. The aim of this study was to compare the clinical efficacy of clinical assessment and NarcotrendTM monitoring during deep-sedated ERCP.
Methods
One hundred patients who underwent ERCP in a single year were randomly assigned to either group C or group N. Patients in group C (52) were sedated using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. Patients in group N (48) were sedated using the NarcotrendTM system. The MOAA/S scale 1 or 2 and the NarcotrendTM index 47–56 to 57–64 were maintained during the procedure. The primary outcome variable of the study was the successful completion of the endoscopic procedure. The secondary outcome variables were the total dose of propofol used during the procedure, complications during and immediately after procedure, and recovery time.
Results
All endoscopies were completed successfully. The mean total dose of propofol in group C was significantly lower than that in group N. However, the mean dose of propofol, expressed as dose/kg or dose/kg/h in both groups, was not significantly different (P = 0.497, 0.136). Recovery time, patient tolerance and satisfaction, and endoscopist satisfaction were comparable between the two groups. All sedation-related adverse events during and immediately after the procedure, such as hypotension, hypertension, tachycardia, bradycardia, transient hypoxia, and upper airway obstruction, in group C (62.2%) were significantly higher than in group N (37.5%) (P = 0.028).
Conclusion
Clinical assessment and NarcotrendTM-guided sedation using propofol for deep sedation demonstrated comparable propofol dose and recovery time. Both monitoring systems were equally safe and effective. However, the NarcotrendTM-guided sedation showed lower hemodynamic changes and fewer complications compared with the clinical assessment-guided sedation.
doi:10.2147/MDER.S17236
PMCID: PMC3417873  PMID: 22915929
deep sedation; endoscopic retrograde cholangiopancreatography; clinical assessment; NarcotrendTM monitoring
9.  Sedation-associated hiccups in adults undergoing gastrointestinal endoscopy and colonoscopy 
AIM: To investigate whether the incidence of hiccups in patients undergoing esophagogastroduodenoscopy (EGD) or same-day bidirectional endoscopy (EGD and colonoscopy; BDE) with sedation is different from those without sedation in terms of quantity, duration and typical onset time.
METHODS: Consecutive patients scheduled for elective EGD or same-day BDE at the gastrointestinal endoscopy unit or the health examination center were allocated to two groups: EGD without sedation (Group A) and BDE with sedation (Group B). The use of sedation was based on the patients’ request. Anesthesiologists participated in this study by administrating sedative drugs as usual. A single experienced gastroenterologist performed both the EGD and the colonoscopic examinations for all the patients. The incidence, duration and onset time of hiccups were measured in both groups. In addition, the association between clinical variables and hiccups were analyzed.
RESULTS: A total of 435 patients were enrolled in the study. The incidences of hiccups in the patients with and without sedation were significantly different (20.5% and 5.1%, respectively). The use of sedation for patients undergoing endoscopy was still significantly associated with an increased risk of hiccups (adjusted odds ratio: 8.79, P < 0.001) after adjustment. The incidence of hiccups in males under sedation was high (67.4%). The sedated patients who received 2 mg midazolam developed hiccups more frequently compared to those receiving 1 mg midazolam (P = 0.0028). The patients with the diagnosis of gastroesophageal reflux disease (GERD) were prone to develop hiccups (P = 0.018).
CONCLUSION: Male patients undergoing EGD or BDE with sedation are significantly more likely to suffer from hiccups compared to those without sedation. Midazolam was significantly associated with an increased risk of hiccups. Furthermore, patients with GERD are prone to develop hiccups.
doi:10.3748/wjg.v18.i27.3595
PMCID: PMC3400863  PMID: 22826626
Anesthesia; Midazolam; Hiccup; Gastroesophageal reflux disease; Esophagogastroduodenoscopy; Bidirectional endoscopy
10.  The Changing Pattern of Upper Gastro-Intestinal Lesions in Southern Saudi Arabia: An Endoscopic Study 
Background/Aim:
Dyspepsia is a common gastrointestinal disorder and is the most common indication for upper gastrointestinal endoscopy (UGIE). In recent years, it has been observed in several centers that there is a change in the causes of dyspepsia as revealed by UGIE. Our main objectives were: (1) To study the pattern of upper gastrointestinal pathology in patients with dyspepsia undergoing upper endoscopy; (2) Compare that with the pattern seen 10-15 years earlier in different areas of KSA.
Patients and Methods:
Retrospective study of all UGI endoscopies performed at Aseer Central Hospital, Abha, Southern Saudi Arabia during the years 2005-2007 on patients above 13 years of age. Patients who underwent UGIE for reasons other than dyspepsia were excluded. The analysis was performed using the SPSS 14 statistical package.
Results:
A total of 1,607 patients underwent UGI endoscopy during the three-year study period (age range, 15-100). There were 907 males (56.4%) and 700 female (43.6%). Normal findings were reported on 215 patients (14%) and the majority had gastritis (676 = 42%), of whom 344 had gastritis with ulcer disease. Moreover, 242 patients (15%) had gastro-esophageal reflux (GERD), with or without esophagitis or hiatus hernia. Also, a total of 243 patients had duodenal ulcer (DU) (15%) while only 12 had gastric ulcer (0.7%).
Discussion and Conclusion:
There is clear change in the frequency of UGIE lesions detected recently compared to a decade ago with an increasing prevalence of reflux esophagitis and hiatus hernia. This could be attributed to changes in lifestyle and dietary habits such as more consumption of fat and fast food, increased prevalence of obesity, and smoking. These problems should be addressed in order to minimize the serious complications of esophageal diseases.
doi:10.4103/1319-3767.58766
PMCID: PMC3023100  PMID: 20065572
Dyspepsia; endoscopy; lesions; esophageal disease
11.  Safety of Gastroenterologist-Guided Sedation with Propofol for Upper Gastrointestinal Therapeutic Endoscopy in Elderly Patients Compared with Younger Patients 
Gut and Liver  2015;9(1):38-42.
Background/Aims
Propofol sedation for elderly patients during time-consuming endoscopic procedures is controversial. Therefore, we investigated the safety of using propofol in elderly patients during upper gastrointestinal therapeutic endoscopy.
Methods
The medical records of 160 patients who underwent therapeutic endoscopic procedures under gastroenterologist-guided propofol sedation at a single institution were retrospectively reviewed. The subjects were divided into two groups: a younger group, patients <75 years old; and an elderly group, patients ≥75 years old. The two groups were compared with respect to the therapeutic regimen, circulatory dynamics, and presence/absence of discontinuation of propofol treatment.
Results
Although the number of patients with liver dysfunction was higher in the elderly group, there were no other significant differences in the baseline characteristics, including the American Society of Anesthesiologists classification, between the elderly and younger groups. The average maintenance rate of continuous propofol infusion was lower in the elderly patients. No statistically significant differences were found in the occurrence of adverse events between the elderly and younger groups. None of the patients returned to a resedated state after the initial recovery from sedation.
Conclusions
Gastroenterologist-guided propofol sedation in elderly patients can be safely achieved in the same manner as that in younger patients, even for time-consuming upper gastrointestinal therapeutic endoscopic procedures.
doi:10.5009/gnl13368
PMCID: PMC4282855  PMID: 25170057
Elderly patient; Propofol; Safety; Sedation; Upper gastrointestinal therapeutic endoscopy
12.  Comparison between the recovery time of alfentanil and fentanyl in balanced propofol sedation for gastrointestinal and colonoscopy: a prospective, randomized study 
BMC Gastroenterology  2012;12:164.
Background
There is increasing interest in balanced propofol sedation (BPS) titrated to moderate sedation (conscious sedation) for endoscopic procedures. However, few controlled studies on BPS targeted to deep sedation for diagnostic endoscopy were found. Alfentanil, a rapid and short-acting synthetic analog of fentanyl, appears to offer clinically significant advantages over fentanyl during outpatient anesthesia.
It is reasonable to hypothesize that low dose of alfentanil used in BPS might also result in more rapid recovery as compared with fentanyl.
Methods
A prospective, randomized and double-blinded clinical trial of alfentanil, midazolam and propofol versus fentanyl, midazolam and propofol in 272 outpatients undergoing diagnostic esophagogastroduodenal endoscopy (EGD) and colonoscopy for health examination were enrolled. Randomization was achieved by using the computer-generated random sequence. Each combination regimen was titrated to deep sedation. The recovery time, patient satisfaction, safety and the efficacy and cost benefit between groups were compared.
Results
260 participants were analyzed, 129 in alfentanil group and 131 in fentanyl group. There is no significant difference in sex, age, body weight, BMI and ASA distribution between two groups. Also, there is no significant difference in recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between two groups. Though deep sedation was targeted, all cardiopulmonary complications were minor and transient (10.8%, 28/260). No serious adverse events including the use of flumazenil, assisted ventilation, permanent injury or death, and temporary or permanent interruption of procedure were found in both groups. However, fentanyl is New Taiwan Dollar (NT$) 103 (approximate US$ 4) cheaper than alfentanil, leading to a significant difference in total cost between two groups.
Conclusions
This randomized, double-blinded clinical trial showed that there is no significant difference in the recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between the two most common sedation regimens for EGD and colonoscopy in our hospital. However, fentanyl is NT$103 (US$ 4) cheaper than alfentanil in each case.
Trial registration
Institutional Review Board of Buddhist Tzu Chi General Hospital (IRB097-18) and Chinese Clinical Trial Registry (ChiCTR-TRC-12002575)
doi:10.1186/1471-230X-12-164
PMCID: PMC3607964  PMID: 23170921
Balanced propofol sedation; Alfentanil; Fentanyl; Deep sedation; Diagnostic endoscopy; Cost benefit
13.  General anesthetic versus light sedation: Effect on pediatric endoscopy wait times 
BACKGROUND:
Wait times are an important measure of health care system effectiveness. There are no studies describing wait times in pediatric gastroenterology for either outpatient visits or endoscopy. Pediatric endoscopy is performed under light sedation or general anesthesia. The latter is hypothesized to be associated with a longer wait time due to practical limits on access to anesthesia in the Canadian health care system.
OBJECTIVE:
To identify wait time differences according to sedation type and measure adverse clinical outcomes that may arise from increased wait time to endoscopy in pediatric patients.
METHODS:
The present study was a retrospective review of medical charts of all patients <18 years of age who had been assessed in the pediatric gastroenterology clinic and were scheduled for an elective outpatient endoscopic procedure at McMaster Children’s Hospital (Hamilton, Ontario) between January 2006 and December 2007. The primary outcome measure was time between clinic visit and date of endoscopy. Secondary outcome measures included other defined waiting periods and complications while waiting, such as emergency room visits and hospital admissions.
RESULTS:
The median wait time to procedure was 64 days for general anesthesia patients and 22 days for patients who underwent light sedation (P<0.0001). There was no significant difference between the two groups with regard to the number of emergency room visits or hospital admissions, both pre- and postendoscopy.
CONCLUSIONS:
Due to the lack of pediatric anesthetic resources, patients who were administered general anesthesia experienced a longer wait time for endoscopy compared with patients who underwent light sedation. This did not result in adverse clinical outcomes in this population.
PMCID: PMC3956006  PMID: 24078936
Endoscopy; Gastroenterology; Pediatrics; Procedural sedation; Wait time
14.  Carbon dioxide accumulation during analgosedated colonoscopy: Comparison of propofol and midazolam 
AIM: To characterize the profiles of alveolar hypoventilation during colonoscopies performed under sedoanalgesia with a combination of alfentanil and either midazolam or propofol.
METHODS: Consecutive patients undergoing routine colonoscopy were randomly assigned to sedation with either propofol or midazolam in an open-labeled design using a titration scheme. All patients received 4 μg/kg per body weight alfentanil for analgesia and 3 L of supplemental oxygen. Oxygen saturation (SpO2) was measured by pulse oximetry (POX), and capnography (PcCO2) was continuously measured using a combined dedicated sensor at the ear lobe. Instances of apnea resulting in measures such as stimulation of the patient, a chin lift, a mask maneuver, or withholding of sedation were recorded. PcCO2 values (as a parameter of sedation-induced hypoventilation) were compared between groups at the following distinct time points: baseline, maximal rise, termination of the procedure and 5 min after termination of the procedure. The number of patients in both study groups who regained baseline PcCO2 values (± 1.5 mmHg) five minutes after the procedure was determined.
RESULTS: A total of 97 patients entered this study. The data from 14 patients were subsequently excluded for clinical procedure-related reasons or for technical problems. Therefore, 83 patients (mean age 62 ± 13 years) were successfully randomized to receive propofol (n = 42) or midazolam (n = 41) for sedation. Most of the patients were classified as American Society of Anesthesiologists (ASA) II [16 (38%) in the midazolam group and 15 (32%) in the propofol group] and ASA III [14 (33%) and 13 (32%) in the midazolam and propofol groups, respectively]. A mean dose of 5 (4-7) mg of IV midazolam and 131 (70-260) mg of IV propofol was used during the procedure in the corresponding study arms. The mean SpO2 at baseline (%) was 99 ± 1 for the midazolam group and 99 ± 1 for the propofol group. No cases of hypoxemia (SpO2 < 85%) or apnea were recorded. However, an increase in PcCO2 that indicated alveolar hypoventilation occurred in both groups after administration of the first drug and was not detected with pulse oximetry alone. The mean interval between the initiation of sedation and the time when the PcCO2 value increased to more than 2 mmHg was 2.8 ± 1.3 min for midazolam and 2.8 ± 1.1 min for propofol. The mean maximal rise was similar for both drugs: 8.6 ± 3.7 mmHg for midazolam and 7.4 ± 3.2 mmHg for propofol. Five minutes after the end of the procedure, the mean difference from the baseline values was significantly lower for the propofol treatment compared with midazolam (0.9 ± 3.0 mmHg vs 4.3 ± 3.7 mmHg, P = 0.0000169), and significantly more patients in the propofol group had regained their baseline value ± 1.5 mmHg (32 of 41 vs 12 of 42, P = 0.0004).
CONCLUSION: A significantly higher number of patients sedated with propofol had normalized PcCO2 values five minutes after sedation when compared with patients sedated with midazolam.
doi:10.3748/wjg.v18.i38.5389
PMCID: PMC3471107  PMID: 23082055
Colonoscopy; Deep sedation; Propofol; Hypoventilation; Blood gas monitoring; Transcutaneous
15.  Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients: study protocol for a randomized controlled trial 
Trials  2012;13:135.
Background
State of the art sedation concepts on intensive care units (ICU) favor propofol for a time period of up to 72 h and midazolam for long-term sedation. However, intravenous sedation is associated with complications such as development of tolerance, insufficient sedation quality, gastrointestinal paralysis, and withdrawal symptoms including cognitive deficits. Therefore, we aimed to investigate whether sevoflurane as a volatile anesthetic technically implemented by the anesthetic-conserving device (ACD) may provide advantages regarding ‘weaning time’, efficiency, and patient’s safety when compared to standard intravenous sedation employing propofol.
Method/Design
This currently ongoing trial is designed as a two-armed, monocentric, randomized prospective phase II study including intubated intensive care patients with an expected necessity for sedation exceeding 48 h. Patients are randomly assigned to either receive intravenous sedation with propofol or sevoflurane employing the ACD. Primary endpoint is the comparison of the ‘weaning time’ defined as the time required from discontinuation of the sedating agent until sufficient spontaneous breathing occurs. Moreover, sedation depth evaluated by Richmond Agitation Sedation Scale and parameters of patient’s safety (that is, vital signs, laboratory monitoring of organ function) as well as the duration of mechanical ventilation and overall stay on the ICU are analyzed and compared. An intention-to-treat analysis will be carried out with all patients for whom it will be possible to define a wake-up time. In addition, a per-protocol analysis is envisaged. Completion of patient recruitment is expected by the end of 2012.
Discussion
This clinical study is designed to evaluate the impact of sevoflurane during long-term sedation of critically ill patients on ‘weaning time’, efficiency, and patient’s safety compared to the standard intravenous sedation concept employing propofol.
Trial registration
EudraCT2007-006087-30; ISCRTN90609144
doi:10.1186/1745-6215-13-135
PMCID: PMC3502585  PMID: 22883020
Inhalative sedation; Intravenous sedation; Intensive care; Sevoflurane
16.  ‘Short’ double-balloon enteroscope for endoscopic retrograde cholangiopancreatography in patients with a surgically altered upper gastrointestinal tract 
The use of endoscopic instruments other than the standard duodenoscope to access anatomical landmarks of the small bowel for certain procedures such as endoscopic retrograde cholangiopancreatography have met with limited success. The double-balloon enteroscope (DBE), however, has revolutionized the ability to access the small bowel, with indications for its use expanding. The DBE has been shown to be safe, effective and less invasive in patients with surgically altered upper gastrointestinal tracts compared with percutaneous transhepatic cholangiography or surgery. This article describes a retrospective review of 20 patients with previous small bowel reconstruction who underwent endoscopic retrograde cholangiopancreatography using a ‘short’ DBE at a major health sciences centre in Toronto, Ontario.
BACKGROUND:
Endoscopic retrograde cholangiopancreatography (ERCP) remains a challenge for endoscopists in patients with surgically altered anatomy of the upper gastrointestinal tract. Double-balloon enteroscopes (DBEs) have revolutionized the ability to access the small bowel. The indication for its therapeutic use is expanding to include ERCP for patients who have undergone small bowel reconstruction. Most of the published experiences in DBE-assisted ERCP have used conventional double-balloon enteroscopes that are 200 cm in length, which do not permit use of the standard ERCP accessories. The authors report their experience with DBE-assisted ERCP using a ‘short’ DBE in patients with surgically altered anatomy.
METHODS:
A retrospective review of patients with previous small bowel reconstruction who underwent ERCP with a ‘short’ DBE at the Centre for Therapeutic Endoscopy and Endoscopic Oncology (Toronto, Ontario) between February 2007 and November 2008 was performed.
RESULTS:
A total of 20 patients (10 men) with a mean age of 57.9 years (range 26 to 85 years) underwent 29 sessions of ERCP with a DBE. Six patients underwent Billroth II gastroenterostomy, seven patients Roux-en-Y hepaticojejunostomy, five patients Roux-en-Y gastrojejunostomy, one patient Roux-en-Y esophagojejunostomy and one patient a Whipple’s operation with choledochojejunostomy. Some patients (n=12 [60%]) underwent previous attempts at ERCP in which the papilla of Vater or bilioenteric anastomosis could not be reached with either a duodenoscope or pediatric colonoscope. All procedures were performed with a commercially available DBE (working length 152 cm, distal end diameter 9.4 mm, channel diameter 2.8 mm). The procedures were performed under conscious sedation with intravenous midazolam, fentanyl and diazepam, except in one patient in whom general anesthesia was administered. Either the papilla of Vater or bilioenteric anastomosis was reached in 25 of 29 cases (86.2%) in a mean duration of 20.8 min (range 5 min to 82 min). Bile duct cannulation was successful in 24 of 25 cases in which the papilla or bilioenteric anastomosis was reached. Therapeutic interventions were successful in 15 patients (24 procedures) including sphincterotomy (n=7), stone extraction (n=9), biliary dilation (n=8), stent placement (n=9) and stent removal (n=8). The mean total duration of the procedures was 70.7 min (range 30 min to 117 min). There were no procedure-related complications.
CONCLUSION:
DBEs enable successful diagnostic and therapeutic ERCP in patients with a surgically altered anatomy of the upper gastrointestinal tract. It is a safe, feasible and less invasive therapeutic option in this group of patients. Standard ‘long’ DBEs have limitations of long working length and the need for modified ERCP accessories. ‘Short’ DBEs are equally as effective in reaching the target limb as standard ‘long’ DBEs, and overcomes some limitations of long DBEs to result in high success rates for endoscopic therapy.
PMCID: PMC3222771  PMID: 22059169
Double-balloon enteroscope; ERCP; Surgically altered upper gastrointestinal tract
17.  Deep sedation during gastrointestinal endoscopy: Propofol-fentanyl and midazolam-fentanyl regimens 
AIM: To compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy.
METHODS: After obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observer’s assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ2 test, measurement of analysis of variance, and the κ statistic.
RESULTS: The times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination.
CONCLUSION: Deep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.
doi:10.3748/wjg.v19.i22.3439
PMCID: PMC3683682  PMID: 23801836
Endoscopy; Deep sedation; Anesthetic administration; Anesthetic dose; Adverse effects
18.  Unsedated transnasal endoscopy: A Canadian experience in daily practice 
BACKGROUND:
Esophagogastroduodenoscopy (EGD) is the most frequently performed diagnostic procedure for upper gastrointestinal disorders. The procedure is routinely performed under conscious sedation in North America. A significant proportion of morbidity and mortality associated with EGD is related to hypoxia due to conscious sedation. The use of sedation is also associated with an increase in cost, loss of work on the day of endoscopy and the need for the patient to be accompanied home after the procedure. Transnasal endoscopy has advantages such as no sedation and less patient monitoring, nursing time and expenses than conventional per oral EGD.
OBJECTIVES:
To assess the feasibility and acceptability of unsedated transnasal EGD in daily practice.
METHODS:
Patients due to undergo EGD were given a choice of either unsedated transnasal EGD or per oral EGD with sedation. Patients who chose unsedated transnasal EGD had the procedure performed in the office by a senior gastroenterologist with experience in transnasal EGD. All procedures were performed using a small-calibre esophagogastroduodenoscope. All patients were surveyed using a patient satisfaction questionnaire, and were asked to give specific scores in terms of choking sensation, sore throat, nasal discomfort and abdominal discomfort. All variables were assessed by scores between 0 and 10, with 10 indicating the most severe degree of each variable. Any complications were also recorded.
RESULTS:
Between March 2002 and August 2003, 231 patients underwent transnasal EGD. The median age of the patients was 57 years (range 15 to 87 years). Complete examinations were possible in 98% of patients. Patients reported a high degree of acceptability (mean score 6.6, range 1 to 10) and low degrees of choking sensation (mean 1.8, range 0 to 10), nasal discomfort (mean 1.7, range 0 to 10), sore throat (mean 0.8, range 0 to 9) and abdominal discomfort (mean 1.1, range 0 to 10). The only complications reported by the patients were epistaxis (n=2, 0.9%) and sinusitis (n=1, 0.4%). Some patients also reported transient light-headedness (n=12, 5%) and mucous discharge (n=2, 0.9%). When asked, 185 patients (88%) stated that they were willing to undergo the same procedure in the future if medically indicated. Of the 84 patients who had conventional EGD under conscious sedation in the past, 52 patients (62%) preferred transnasal EGD without sedation.
CONCLUSIONS:
Transnasal EGD is generally well tolerated, feasible and safe. It can be performed with topical anesthesia in an outpatient setting. The low complication rate, high patient satisfaction and potential cost savings make transnasal endoscopy an attractive alternative to conventional EGD to screen patients for upper gastrointestinal tract diseases.
PMCID: PMC2662198  PMID: 18354752
EGD; Sedation; Transnasal endoscopy
19.  Conscious or unconscious: The impact of sedation choice on colon adenoma detection 
AIM: To determine if anesthesiologist-monitored use of propofol results in improved detection of adenomas when compared with routine conscious sedation.
METHODS: This retrospective study was conducted at two separate hospital-based endoscopy units where approximately 12 000 endoscopic procedures are performed annually, with one endoscopy unit exclusively using anesthesiologist-monitored propofol. Three thousand two hundred and fifty-two patients underwent initial screening or surveillance colonoscopies. Our primary end point was the adenoma detection rate, defined as the number of patients in whom at least one adenoma was found, associated with the type of sedation.
RESULTS: Three thousand two hundred and fifty-two outpatient colonoscopies were performed by five selected endoscopists. At least one adenoma was detected in 27.6% of patients (95% CI = 26.0-29.1) with no difference in the detection rate between the anesthesiologist -propofol and group and the gastroenterologist-midazolam/fentanyl group (28.1% vs 27.1%, P = 0.53).
CONCLUSION: The type of sedation used during co-lonoscopy does not affect the number of patients in whom adenomatous polyps are detected.
doi:10.3748/wjg.v17.i34.3912
PMCID: PMC3198020  PMID: 22025879
Sedation; Colonoscopy; Adenoma
20.  The Effect of Sedation During Upper Gastrointestinal Endoscopy 
Background/Aim:
We aimed to study whether sedation reduces discomfort during endoscopy and a comparison of longer-acting diazepam with shorter-acting midazolam.
Patients and Methods:
A prospective, randomized, single-blinded study was conducted at the Department of Medicine at Government Medical College and Hospital, Chandigarh, and was completed over a period of 6 months. The patients were randomized to receive either placebo or sedation with midazolam or diazepam before endoscopy. The endoscopist and the observer recording patient’s/physician’s responses were blinded to the drugs administered. Two hundred and fifty two consecutive patients undergoing diagnostic or therapeutic upper gastrointestinal endoscopy were recruited. The patient’s discomfort and the physician’s comfort during the procedure were recorded on a visual analogue scale rated from 1-10 with-in 10 minutes of the procedure by an independent observer. The Patient’s discomfort ratings were further divided into 3 groups, comfortable (score, 1-3), satisfactory (score, 4-7) and uncomfortable (a score of >7). Similarly the physician’s ease of performing the procedure was also recorded on the same scale. This was again divided into 3 groups: easy (score, 1-3), satisfactory (score, 4-7) and difficult (a score of >7).
Results:
Out of the total of 252 patients, 82 patients received no sedation (group I), 85 received diazepam (group II) and 85 received midazolam (group III). There was no statistical difference in the discomfort experienced by the patients during endoscopy when sedation was used (P=0.0754). Out of 252 patients, 49 underwent endoscopic procedures. Nineteen patients were included in group I, 18 in group II and 12 in group III. Only 10 (20%) patients undergoing endoscopic procedures complained of significant discomfort, but there was no difference in the ones undergoing interventions with or without sedation (P=0.854). The physicians were more comfortable in performing endoscopic procedure in sedated patients, however, the difference between patients in group II and group III was not statistically significant (P=0.0461). Both diazepam and midazolam fared equally well in increasing physician’s comfort (P=0.617).
Conclusion:
There was no difference in the patient’s discomfort with regard to the sedative used (midazolam or diazepam). Although endoscopy was easy or satisfactory in the majority of patients in the unsedated as well as the sedated groups, more often the endoscopist found it difficult to do endoscopy on the unsedated patients.
doi:10.4103/1319-3767.70616
PMCID: PMC2995098  PMID: 20871194
Endoscopic procedures; gastrointestinal endoscopy; patient’s perception; sedation
21.  Stepwise sedation for elderly patients with mild/moderate COPD during upper gastrointestinal endoscopy 
AIM: To investigate stepwise sedation for elderly patients with mild/moderate chronic obstructive pulmonary disease (COPD) during upper gastrointestinal (GI) endoscopy.
METHODS: Eighty-six elderly patients with mild/moderate COPD and 82 elderly patients without COPD scheduled for upper GI endoscopy were randomly assigned to receive one of the following two sedation methods: stepwise sedation involving three-stage administration of propofol combined with midazolam [COPD with stepwise sedation (group Cs), and non-COPD with stepwise sedation (group Ns)] or continuous sedation involving continuous administration of propofol combined with midazolam [COPD with continuous sedation (group Cc), and non-COPD with continuous sedation (group Nc)]. Saturation of peripheral oxygen (SpO2), blood pressure, and pulse rate were monitored, and patient discomfort, adverse events, drugs dosage, and recovery time were recorded.
RESULTS: All endoscopies were completed successfully. The occurrences of hypoxemia in groups Cs, Cc, Ns, and Nc were 4 (9.3%), 12 (27.9%), 3 (7.3%), and 5 (12.2%), respectively. The occurrence of hypoxemia in group Cs was significantly lower than that in group Cc (P < 0.05). The average decreases in value of SpO2, systolic blood pressure, and diastolic blood pressure in group Cs were significantly lower than those in group Cc. Additionally, propofol dosage and overall rate of adverse events in group Cs were lower than those in group Cc. Finally, the recovery time in group Cs was significantly shorter than that in group Cc, and that in group Ns was significantly shorter than that in group Nc (P < 0.001).
CONCLUSION: The stepwise sedation method is effective and safer than the continuous sedation method for elderly patients with mild/moderate COPD during upper GI endoscopy.
doi:10.3748/wjg.v19.i29.4791
PMCID: PMC3732854  PMID: 23922479
Upper gastrointestinal endoscopy; Adverse events; Sedation; Monitoring; Chronic obstructive pulmonary disease
22.  Procedural sedation analgesia 
Saudi Journal of Anaesthesia  2010;4(1):11-16.
The number of noninvasive and minimally invasive procedures performed outside of the operating room has grown exponentially over the last several decades.Sedation, analgesia, or both may be needed for many of these interventional or diagnostic procedures. Individualized care is important when determining if a patient requires procedural sedation analgesia (PSA). The patient might need an anti-anxiety drug, pain medicine, immobilization, simple reassurance, or a combination of these interventions. The goals of PSA in four different multidisciplinary practices namely; emergency, dentistry, radiology and gastrointestinal endoscopy are discussed in this review article. Some procedures are painful, others painless. Therefore, goals of PSA vary widely. Sedation management can range from minimal sedation, to the extent of minimal anesthesia. Procedural sedation in emergency department (ED) usually requires combinations of multiple agents to reach desired effects of analgesia plus anxiolysis. However, in dental practice, moderate sedation analgesia (known to the dentists as conscious sedation) is usually what is required. It is usually most effective with the combined use of local anesthesia. The mainstay of success for painless imaging is absolute immobility. Immobility can be achieved by deep sedation or minimal anesthesia. On the other hand, moderate sedation, deep sedation, minimal anesthesia and conventional general anesthesia can be all utilized for management of gastrointestinal endoscopy.
doi:10.4103/1658-354X.62608
PMCID: PMC2900045  PMID: 20668560
Conscious sedation; deep sedation; minimal anesthesia; procedural sedation
23.  Propofol-based deep sedation for endoscopic retrograde cholangiopancreatography procedure in sick elderly patients in a developing country 
Introduction:
The aim of this study was to evaluate and compare the clinical efficacy of propofol-based deep sedation (PBDS) for endoscopic retrograde cholangiopancreatography (ERCP) procedure in sick (American Society of Anesthesiologists [ASA] physical status III–IV) and nonsick (ASA physical status I–II) elderly patients in a teaching hospital in Thailand.
Methods:
We undertook a retrospective review of the anesthesia or sedation service records of elderly patients who underwent ERCP procedures from October 2007 to September 2008. All patients were classified into two groups according to the ASA physical status. In group A, the patients had ASA physical status I–II, while in group B, the patients had ASA physical status III–IV. The primary outcome variable of the study was the successful completion of the procedure. The secondary outcome variables were sedation-related adverse events during and immediately after the procedure.
Results:
There were 158 elderly patients who underwent ERCP procedure by using PBDS during the study period. Of these, 109 patients were in group A and 49 patients were in group B. There were no significant differences in age, gender, weight, duration of ERCP, indication of procedure, and the mean dose of fentanyl, propofol, and midazolam between the two groups. All patients in both groups successfully completed the procedure except eight patients in group A and three patients in group B (P = 0.781). Overall, respiratory and cardiovascular adverse events in both groups were not significantly different. All adverse events were easily treated, with no adverse sequelae.
Conclusion:
In the setting of a developing country, PBDS for ERCP procedure in sick elderly patients by trained anesthetic personnel with appropriate monitoring was safe and effective. The clinical efficacy of this technique in sick elderly patients was not different or worse than in nonsick elderly patients. Serious adverse events were rare in our population.
doi:10.2147/TCRM.S21519
PMCID: PMC3132095  PMID: 21753887
deep sedation; endoscopic retrograde cholangiopancreatography; propofol (ERCP); sick; elderly; American Society of Anesthesiologists (ASA); developing country
24.  Propofol Sedation for ERCP Procedures: A Dilemna? Observations from an Anesthesia Perspective 
Propofol sedation for endoscopic retrograde cholangiopancreatography (ERCP) procedures is a popular current technique that has generated controversy in the medical field. Worldwide, both anesthetic and nonanesthetic personnel administer this form of sedation. Although the American and Canadian societies of gastroenterologists have endorsed the administration of propofol by nonanesthesia personnel, the US Food and Drug Administration (FDA) has not licensed its use in this manner. There is some evidence for the safe use of propofol by nonanesthetic personnel in patients undergoing endoscopy procedures, but there are few randomized trials addressing the safety and efficacy of propofol in patients undergoing ERCP procedures. A serious possible consequence of propofol sedation in patients is that it may result in rapid and unpredictable progression from deep sedation to general anesthesia, and skilled airway support may be required as a rescue measure. Potential complications following deep propofol sedation include hypoxemia and hypotension. Propofol sedation for ERCP procedures is an area of clinical practice where discussion and mutual cooperation between anesthesia and nonanesthesia personnel may enhance patient safety.
doi:10.1155/2012/639190
PMCID: PMC3261459  PMID: 22272061
25.  The impact of diphenhydramine and promethazine in patients undergoing advanced upper endoscopic procedures 
Background
Endoscopic retrograde cholangiopancreatography (ERCP ) and endoscopic ultrasound (EUS) procedures are more complex and longer duration than standard endoscopy, requiring deeper levels of sedation. While prior studies have compared standard sedation (meperidine and midazolam) to propofol, no randomized, controlled trials have evaluated the use of adjunct sedatives in these procedures.
Aims
To prospectively compare the use of promethazine and diphenhydramine as adjunct sedatives to standard sedation in patients undergoing advanced endoscopic procedures.
Methods
This was a prospective, randomized, placebo-controlled study in a single, tertiary-care referral center. Promethazine (P), diphenhydramine (B), or normal saline (NS) were given as adjunct sedatives along with meperidine and midazolam in adult patients undergoing upper EUS and/or ERCP procedures. The main outcome measurement was sedation failure.
Results
292 patients (P: 97, B: 93, NS: 102) were randomized over 36 months. No significant differences in sedation failures (P: 8, B: 13, NS: 11, p=0.449) or in the times needed to achieve adequate sedation (P: 11.8 minutes, B: 12.9 minutes, NS: 14.0 minutes, p=0.054) were seen between the groups. Sedation using P (43.7 minutes) was associated with a significantly longer recovery time compared to B (28.0 minutes) or NS (24.5 minutes).
Conclusions
The use of promethazine and diphenhydramine as adjunct sedatives did not improve sedation failure rates or reduce the time needed to achieve sedation in patients undergoing upper EUS or ERCP. Patients with anticipated sedation difficulties should proceed directly to propofol-based sedation.
doi:10.7178/jig.124
PMCID: PMC3896573  PMID: 24498528
promethazine; diphenhydramine; endoscopic retrograde cholangiopancreatography; endoscopic ultrasound; sedation

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