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Objectives

To observe procedural sedation practice within a district general hospital emergency department (ED) that uses propofol for procedural sedation.

Methods

Prospective observation of procedural sedation over an 11 month period. Patients over 16 years of age requiring procedural sedation and able to give informed consent were recruited. The choice of sedation agent was at the discretion of the physician. The following details were recorded on a standard proforma for each patient: indication for procedural sedation; agent used; depth and duration of sedation; ease of reduction; use of a reversal agent; complications and reasons for delayed discharge from the ED.

Results

48 patients were recruited; propofol was used in 32 cases and midazolam in 16 cases. The median period of sedation was considerably shorter in the propofol group (3 vs 45 min) but this did not confer a shorter median time in the ED (200 vs 175 min). There were no documented cases of over‐sedation in the propofol group; however, four patients in the midazolam group were over‐sedated, three requiring reversal with flumazenil. There were no other significant complications in either group. There was no difference in the median depth of sedation achieved or ease of reduction between the two groups.

Conclusions

Propofol is effective and safe for procedural sedation in the ED. Propofol has a considerably shorter duration of action than midazolam, thereby shortening the period of sedation.

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.

OBJECTIVES

The purpose of this study was to determine the total propofol dose (mg/kg) for non-emergent pediatric procedural sedation and evaluate dosing differences with regard to a patient's sex, age, and body mass index. Adverse events were recorded and evaluated to determine whether certain patient groups were at a higher risk than others.

METHODS

This study was a retrospective observational pilot study including patients 0 to 18 years of age admitted between January 2008 and November 2009 for non-emergent gastrointestinal endoscopic procedures or radiologic imaging, who received propofol for procedural sedation. Data gathered included sex, age, height, weight, chronic medical conditions and medication use, concomitant anesthetic gas, preprocedure midazolam, procedure length, propofol dose in mg/kg, other medications administered during procedure, and adverse events that occurred. Comparisons between adverse event groups and categories of baseline characteristics were made using the Wilcoxon signed-rank, Kruskal-Wallis nonparametric and Pearson's chisquare tests, as appropriate.

RESULTS

A total of 101 patients met inclusion criteria and were included in the analysis. The mean dose of propofol required for female patients was 3.7 mg/kg versus 3.4 mg/kg for males (p=0.3). The mean dose of propofol for patients ≤9 years, 10 to 12 years, and >12 years was 3.2, 3.9, and 3.9 mg/kg, respectively (p=0.25). The mean dose of propofol for underweight, healthy weight, overweight, and obese patients was 4.2, 3.9, 3.6, and 2.6 mg/kg, respectively (p=0.38). Hypotension occurred in 42.6% of patients, and bradycardia occurred in 13.9% of patients.

CONCLUSIONS

There were no differences in dose requirements based on sex or age. The difference in dosing between different body weight categories was not statistically significant. The dose of propofol was higher in patients that experienced bradycardia and hypotension, but there was no statistical significance. Given the above, future studies with larger sample sizes should be conducted to establish if statistical significance exists.

Diagnostic and therapeutic endoscopy can successfully be performed by applying moderate (conscious) sedation. Moderate sedation, using midazolam and an opioid, is the standard method of sedation, although propofol is increasingly being used in many countries because the satisfaction of endoscopists with propofol sedation is greater compared with their satisfaction with conventional sedation. Moreover, the use of propofol is currently preferred for the endoscopic sedation of patients with advanced liver disease due to its short biologic half-life and, consequently, its low risk of inducing hepatic encephalopathy. In the future, propofol could become the preferred sedation agent, especially for routine colonoscopy. Midazolam is the benzodiazepine of choice because of its shorter duration of action and better pharmacokinetic profile compared with diazepam. Among opioids, pethidine and fentanyl are the most popular. A number of other substances have been tested in several clinical trials with promising results. Among them, newer opioids, such as remifentanil, enable a faster recovery. The controversy regarding the administration of sedation by an endoscopist or an experienced nurse, as well as the optimal staffing of endoscopy units, continues to be a matter of discussion. Safe sedation in special clinical circumstances, such as in the cases of obese, pregnant, and elderly individuals, as well as patients with chronic lung, renal or liver disease, requires modification of the dose of the drugs used for sedation. In the great majority of patients, sedation under the supervision of a properly trained endoscopist remains the standard practice worldwide. In this review, an overview of the current knowledge concerning sedation during digestive endoscopy will be provided based on the data in the current literature.

Background/Aims

Endoscopic submucosal dissection (ESD) is accepted as a treatment for gastric neoplasms and usually requires deep sedation. The aim of this study was to evaluate the safety and efficacy profiles of deep sedation induced by continuous propofol infusion with or without midazolam during ESD.

Methods

A total of 135 patients scheduled for ESDs between December 2008 and June 2010 were included in this prospective study and were randomly assigned to one of two groups: the propofol group or the combination group (propofol plus midazolam).

Results

The propofol group reported only one case of severe hypoxemia with no need of mask ventilation or intubation. Additionally, 18 cases of mild hypotension were observed in the propofol group, and 11 cases were observed in the combination group. The combination group had a lower mean total propofol dose (378 mg vs 466 mg, p<0.012), a longer mean recovery time (10.5 minutes vs 7.9 minutes, p=0.027), and a lower frequency of overall adverse events (32.8% vs 17.6%, p=0.042).

Conclusions

Deep sedation induced by continuous propofol infusion was shown to be safe during ESD. The combination of continuous propofol infusion and intermittent midazolam injection can decrease the total dose and infusion rate of propofol and the overall occurrence of adverse events.

Objectives. To review our sedation practice and to evaluate the clinical effectiveness of an anesthesiologist-administered intravenous sedation outside of the main operating room for pediatric upper gastrointestinal endoscopy (UGIE) in Thailand. Subjects and Methods. We undertook a retrospective review of the sedation service records of pediatric patients who underwent UGIE. All endoscopies were performed by a pediatric gastroenterologist. All sedation was administered by staff anesthesiologist or anesthetic personnel. Results. A total of 168 patients (94 boys and 74 girls), with age from 4 months to 12 years, underwent 176 UGIE procedures. Of these, 142 UGIE procedures were performed with intravenous sedation (IVS). The mean sedation time was 23.2 ± 10.0 minutes. Propofol was the most common sedative drugs used. Mean dose of propofol, midazolam and fentanyl was 10.0 ± 7.5 mg/kg/hr, 0.2 ± 0.2 mg/kg/hr, and 2.5 ± 1.2 mcg/kg/hr, respectively. Complications relatively occurred frequently. All sedations were successful. However, two patients became more deeply than intended and required unplanned endotracheal intubation. Conclusion. The study shows the clinical effectiveness of an anesthesiologist-administered IVS outside of the main operating room for pediatric UGIE in Thailand. All complications are relatively high. We recommend the use of more sensitive equipments such as end tidal CO2 and carefully select more appropriate patients.

Conscious sedation has been the standard of care for many years for gastrointestinal endoscopic procedures. As procedures have become more complex and lengthy, additional medications became essential for adequate sedation. Often time’s deep sedation is required for procedures such as endoscopic retrograde cholangiography which necessitates higher doses of narcotics and benzodiazepines or even use of other medications such as ketamine. Given its pharmacologic properties, propofol was rapidly adopted worldwide to gastrointestinal endoscopy for complex procedures and more recently to routine upper and lower endoscopy. Many studies have shown superiority for both the physician and patient compared to standard sedation. Nevertheless, its use remains highly controversial. A number of studies worldwide show that propofol can be given safely by endoscopists or nurses when well trained. Despite this wealth of data, at many centers its use has been prohibited unless administered by anesthesiology. In this commentary, we review the use of anesthesia support for endoscopy in the United States based on recent data and its implications for gastroenterologists worldwide.

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.

Background/Aims

For proper sedation during endoscopic submucosal dissection (ESD), propofol has been widely used. This study aimed to compare the levels of sedation and tolerance of patients treated with midazolam (M group) and a combination of midazolam and propofol (MP group) during ESD.

Methods

A total of 44 consecutive patients undergoing ESD were randomly assigned to the two groups. In the M group, 2 mg of midazolam was given repeatedly to maintain after a loading dose of 5 mg. The MP group initially received 5 mg of midazolam and 20 mg of propofol. Then, we increased the dosage of propofol by 20 mg gradually.

Results

The average amount of midazolam was 12 mg in the M group. In the M group, 10 patients were given propofol additionally, since they failed to achieve proper sedation. The average amount of propofol was 181 mg in the MP group. Procedure time, vital signs and rates of complications were not significantly different between two groups. Movement of patients and discomfort were lower in the MP group.

Conclusions

During ESD, treatment with propofol and a low dose of midazolam for sedation provides greater satisfaction for endoscopists compared to midazolam alone.

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.

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.

For dental outpatients undergoing conscious sedation, recovery from sedation must be sufficient to allow safe discharge home, and many researchers have defined "recovery time" as the time until the patient was permitted to return home after the end of dental treatment. But it is frequently observed that patients remain in the clinic after receiving permission to go home. The present study investigated "clinical recovery time," which is defined as the time until discharge from the clinic after a dental procedure. We analyzed data from 61 outpatients who had received dental treatment under conscious sedation at the Hiroshima University Dental Hospital between January 1998 and December 2000 (nitrous oxide-oxygen inhalation sedation [n = 35], intravenous sedation with midazolam [n = 10], intravenous sedation with propofol [n = 16]). We found that the median clinical recovery time was 40 minutes after nitrous oxide-oxygen sedation, 80 minutes after midazolam sedation, and 52 minutes after propofol sedation. The clinical recovery time was about twice as long as the recovery time described in previous studies. In a comparison of the sedation methods, clinical recovery time differed (P = .0008), being longer in the midazolam sedation group than in the nitrous oxide-oxygen sedation group (P = .018). These results suggest the need for changes in treatment planning for dental outpatients undergoing conscious sedation.

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.

A prospective audit of upper gastrointestinal endoscopy in 36 hospitals across two regions provided data from 14,149 gastroscopies of which 1113 procedures were therapeutic and 13,036 were diagnostic. Most patients received gastroscopy under intravenous sedation; midazolam was the preferred agent in the North West and diazepam was preferred in East Anglia. Mean doses of each agent used were 5.7 mg and 13.8 mg respectively, although there was a wide distribution of doses reported. Only half of the patients endoscoped had some form of intravenous access in situ and few were supplied with supplementary oxygen. The death rate from this study for diagnostic endoscopy was 1 in 2000 and the morbidity rate was 1 in 200; cardiorespiratory complications were the most prominent in this group and there was a strong relation between the lack of monitoring and use of high dose benzodiazepines and the occurrence of adverse outcomes. In particular there was a link between the use of local anaesthetic sprays and the development of pneumonia after gastroscopy (p < 0.001). Twenty perforations occurred out of a total of 774 dilatations of which eight patients died (death rate 1 in 100). A number of units were found to have staffing problems, to be lacking in basic facilities, and to have poor or virtually non-existent recovery areas. In addition, a number of junior endoscopists were performing endoscopy unsupervised and with minimal training.

Propofol (2,6,di-isopropylphenol) was given by continuous intravenous infusion to provide sedation after cardiac surgery in 30 patients and its effects compared with those of midazolam given to a further 30 patients. Propofol infusion allowed rapid and accurate control of the level of sedation, which was satisfactory for longer than with midazolam. Patients given propofol recovered significantly more rapidly from their sedation once they had fulfilled the criteria for weaning from artificial ventilation and as a result spent a significantly shorter time attached to a ventilator. There were no serious complications in either group. Both medical and nursing staff considered the propofol infusion to be superior to midazolam in these patients. These findings suggest that propofol is a suitable replacement for etomidate and alphaxalone-alphadolone for sedating patients receiving intensive care.

Patient-controlled sedation was utilized in patients aged 15 to 85 yr who were undergoing surgery under local or regional anesthesia. Midazolam, propofol, and methohexitone were used, either by themselves or in combination with fentanyl or alfentanil. Sedation was mild to moderate in the majority of patients, and operating conditions were good. The sedation method provided patients the ability to control the sedation and to vary the degree of sedation according to the environment and to the stress of the procedure. Sedation of the elderly, which tends to be problematic, was made easy using this method, and the elderly patients appeared to enjoy the option. The problems encountered were oversedation, respiratory depression, pain during injection, and postural hypotension.

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Background

This study examined the safety and effectiveness of the procedural sedation analgesia (PSA) technique carried out in the emergency department (ED) of a university hospital over a period of 1 year. The research was done to compare the effectiveness and efficacy of moderate sedation of fentanyl combined with either midazolam or propofol for any brief, intense procedure in the ED setting.

Aims

The objectives were to observe the occurrence of adverse events in subjects undergoing PSA for intense and painful procedures in the emergency department and to implement the use of capnography as a method of monitoring the patients when they were under PSA.

Methods

Forty patients were selected for this study. They were randomly divided into two equal groups using the computer-generated random permuted blocks of four patients. Twenty patients were grouped together as group A and the remaining 20 patients as group B. Drugs used were single blinded to prevent any bias. Drug A was propofol and fentanyl, while drug B was midazolam and fentanyl. The procedures involved included orthopedic manipulation such as reduction of fractures, reduction of dislocated joints, abscess drainage, wound debridement, laceration wound repair and cardioversion. All of the subjects were monitored for their vital signs and end tidal carbon dioxide level every 10 min till the PSA was completed. The duration of stay in the ED was documented when the subjects had completed the procedure and were released from the department.

Result

Of the study population, 75.6% were males. The mean age was 37.8 years (95% CI 33.2, 39.8). None of the patients developed any major complications while under PSA. The vital signs pre-, intra- and post-procedure were not significantly different in either the propofol or mizadolam groups (p value >0.05).

Conclusion

This study had proven that there was no difference in adverse event occurrence between the studied drugs during PSA. Propofol can be recommended for use in PSA if the operator is well trained and familiar with the drug.

Objectives—This study compared intranasal midazolam (INM) with a combination of intravenous ketamine and intravenous midazolam (IVKM) for sedation of children requiring minor procedures in the emergency department.

Method—A single blinded randomised clinical trial was conducted in the emergency department of a major urban paediatric hospital. Subjects requiring sedation for minor procedures were randomised to receive either INM (0.4 mg/kg) or intravenous ketamine (1 mg/kg) plus intravenous midazolam (0.1 mg/kg). Physiological variables and two independent measures of sedation (Sedation Score and Visual Analogue Sedation Scale) were recorded before sedation and at regular intervals during the procedure and recovery period. Times to adequate level of sedation and to discharge were compared.

Results—Fifty three patients were enrolled over a 10 month period. Sedation was sufficient to complete the procedures in all children receiving IVKM and in 24 of the 26 receiving INM. Onset of sedation was an average of 5.3 minutes quicker with IVKM than with INM (95%CI 3.2, 7.4 minutes, p<0.001). Children given INM were discharged an average of 19 minutes earlier than those given IVKM (95%CI 4, 33 minutes, p=0.02). Mean Sedation Scores and Visual Analogue Sedation Scale scores for the 30 minutes after drug administration were significantly better in children given IVKM compared with INM (2.4 and 1.8 versus 3.5 and 3.8, respectively). Both doctors and parents were more satisfied with sedation by intravenous ketamine and midazolam.

Conclusions—Intravenous ketamine plus midazolam used in an appropriate setting by experienced personnel provides an excellent means of achieving sedation suitable for most non-painful minor procedures for children in the emergency department. This combination is superior to INM in terms of speed of onset and consistency of effect. INM delivered via aerosol spray has a more variable effect but may still be adequate for the completion of many of these procedures.

AIM: To evaluate the effectiveness of outpatient percutaneous endoscopic gastrostomy (PEG) replacement using esophagogastroduodenoscopy (EGD) and propofol sedation.

METHODS: We retrospectively assessed the outcome and complications of consecutive patients referred for PEG replacement which was performed using EGD under propofol sedation in the outpatient setting. The success rate, the mean dose of propofol, procedure time, EGD findings, discharge time from endoscopy unit, respiratory depression, and complications within 72 h of the procedure were evaluated. In a subset of these patients, the blood concentrations of propofol were measured.

RESULTS: All 221 patients underwent successful PEG replacement. The mean dose of propofol was 34 mg (range, 20-60 mg) with a mean procedure time of 5.9 min (range, 3-8 min). Reflux esophagitis (12 patients), gastric ulcer (5), gastric neoplasm (2), and duodenal ulcer (1) were newly diagnosed at replacement. Discharge from endoscopy unit was possible in 100% of patients 45 min after the procedure. Only 3.6% (8) required transient supplemental oxygen. No complications occurred within 72 h of the procedure. During EGD the level of sedation and propofol blood concentrations after administration of propofol (30 mg) in these PEG patients corresponded to those of propofol (60 mg) in middle aged subjects (control).

CONCLUSION: PEG replacement using EGD and propofol sedationin the outpatient setting was safe and practical.

Background

To study the relationship between endoscopic practice and adverse events during colonoscopy under standard deep sedation induced and monitored by an anesthetist.

Methods

We investigated the routine activity of an endoscopy center at the Padova University teaching hospital. We considered not only endoscopic and cardiorespiratory complications, but also the need to use high-dose propofol to complete the procedure, and the inability to complete the procedure. Variables relating to the patient’s clinical conditions, bowel preparation, the endoscopist’s and the anesthetist’s experience, and the duration of the procedure were input in the model.

Results

617 procedures under deep sedation were performed with a 5% rate of adverse events. The average dose of propofol used was 2.6±1.2 mg/kg. In all, 14 endoscopists and 42 anesthetists were involved in the procedures. The logistic regression analysis identified female gender (OR=2.3), having the colonoscopy performed by a less experienced endoscopist (OR=1.9), inadequate bowel preparation (OR=3.2) and a procedure lasting longer than 17.5 minutes (OR=1.6) as the main risk factors for complications. An ASA score of 2 carried a 50% risk reduction (OR=0.5).

Discussion and conclusions

Our model showed that none of the variables relating to anesthesiological issues influenced which procedures would prove difficult.

Propofol (2,6-diisopropylphenol) is an ultrashort-acting sedative agent with sedative and amnestic effects that is used not only for anesthesia but also for sedation during minor outpatient procedures and endoscopic examinations. Rare cases of anaphylaxis following propofol administration have been reported in the medical literature. Documentation of anaphylaxis is often lacking because the cause and effect relationship is often hard to prove. Only a minority of patients get referred for allergy testing to confirm the offending drug. Here we report a 74-year-old woman who had an anaphylactic reaction with severe oropharyngeal edema and bronchospasm for a few minutes after receiving propofol during endoscopic examination. An allergy skin test was positive for both propofol and soybean. Soybean in the intralipid is one component of propofol, and we concluded that this anaphylaxis was caused by soybean.

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.

Summary

Regional anaesthesia has become an important anaesthetic technique. Effective sedation is an essential for regional techniques too. This study compares midazolam and propofol in terms of onset & recovery from sedation, dosage and side effects of both the drugs using Bispectral Index monitoring. Ninety eight patients were randomly divided into two groups,one group recieved midazolam infusion while the other recieved propofol infusion until BIS reached 75. We observed Time to reach desired sedation, HR, MABP, time for recovery, dose to reach sedation and for maintenance of sedation and side effects if any. The time to reach required sedation was 11 min in Midazolam group(Group I) while it was 6 min in Propofol group(Group II) (p=0.0). Fall in MABP was greater with propofol. Recovery in with midazolam was slower than with propofol (18.6 ± 6.5 vs 10.10±3.65 min) (p=0.00). We concluded that both midazolam and propofol are effective sedatives, but onset and offset was quicker with propofol, while midazolam was more cardiostable.

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

Introduction

Hospitals are increasingly forced to consider the economics of technology use. We estimated the incremental cost-consequences of remifentanil-based analgo-sedation (RS) vs. conventional analgesia and sedation (CS) in patients requiring mechanical ventilation (MV) in the intensive care unit (ICU), using a modelling approach.

Methods

A Markov model was developed to describe patient flow in the ICU. The hourly probabilities to move from one state to another were derived from UltiSAFE, a Dutch clinical study involving ICU patients with an expected MV-time of two to three days requiring analgesia and sedation. Study medication was either: CS (morphine or fentanyl combined with propofol, midazolam or lorazepam) or: RS (remifentanil, combined with propofol when required). Study drug costs were derived from the trial, whereas all other ICU costs were estimated separately in a Dutch micro-costing study. All costs were measured from the hospital perspective (price level of 2006). Patients were followed in the model for 28 days. We also studied the sub-population where weaning had started within 72 hours.

Results

The average total 28-day costs were €15,626 with RS versus €17,100 with CS, meaning a difference in costs of €1474 (95% CI -2163, 5110). The average length-of-stay (LOS) in the ICU was 7.6 days in the RS group versus 8.5 days in the CS group (difference 1.0, 95% CI -0.7, 2.6), while the average MV time was 5.0 days for RS versus 6.0 days for CS. Similar differences were found in the subgroup analysis.

Conclusions

Compared to CS, RS significantly decreases the overall costs in the ICU.

Trial Registration

Clinicaltrials.gov NCT00158873.