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1.  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.
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.
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.
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.
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)
PMCID: PMC3607964  PMID: 23170921
Balanced propofol sedation; Alfentanil; Fentanyl; Deep sedation; Diagnostic endoscopy; Cost benefit
2.  Propofol-based deep sedation for endoscopic retrograde cholangiopancreatography procedure in sick elderly patients in a developing country 
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.
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.
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.
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.
PMCID: PMC3132095  PMID: 21753887
deep sedation; endoscopic retrograde cholangiopancreatography; propofol (ERCP); sick; elderly; American Society of Anesthesiologists (ASA); developing country
3.  Deep sedation for endoscopic retrograde cholangiopancreatography: a comparison between clinical assessment and NarcotrendTM monitoring 
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.
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.
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).
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.
PMCID: PMC3417873  PMID: 22915929
deep sedation; endoscopic retrograde cholangiopancreatography; clinical assessment; NarcotrendTM monitoring
4.  Sedation in Adults Receiving Mechanical Ventilation: Physiological and Comfort Outcomes 
To describe the relationships among sedation, stability in physiological status, and comfort during a 24-hour period in patients receiving mechanical ventilation.
Data from 169 patients monitored continuously for 24 hours were recorded at least every 12 seconds, including sedation levels, physiological status (heart rate, respiratory rate, oxygen saturation by pulse oximetry), and comfort (movement of arms and legs as measured by actigraphy). Generalized linear mixed-effect models were used to estimate the distribution of time spent at various heart and respiratory rates and oxygen saturation and actigraphy intervals overall and as a function of level of sedation and to compare the percentage of time in these intervals between the sedation states.
Patients were from various intensive care units: medical respiratory (52%), surgical trauma (35%), and cardiac surgery (13%). They spent 42% of the time in deep sedation, 38% in mild/moderate sedation, and 20% awake/alert. Distributions of physiological measures did not differ during levels of sedation (deep, mild/moderate, or awake/alert: heart rate, P = .44; respirations, P = .32; oxygen saturation, P = .51). Actigraphy findings differed with level of sedation (arm, P < .001; leg, P = .01), with less movement associated with greater levels of sedation, even though patients spent the vast majority of time with no arm movement or leg movement.
Level of sedation most likely does not affect the stability of physiological status but does have an effect on comfort.
PMCID: PMC3703630  PMID: 22549581
5.  Deep sedation for endoscopic retrograde cholangiopacreatography 
Sedation and analgesia comprise an important element of unpleasant and often prolonged endoscopic retrograde cholangiopacreatography (ERCP), contributing, however, to better patient tolerance and compliance and to the reduction of injuries during the procedure due to inappropriate co-operation. Although most of the studies used a moderate level of sedation, the literature has revealed the superiority of deep sedation and general anesthesia in performing ERCP. The anesthesiologist’s presence is mandatory in these cases. A moderate sedation level for ERCP seems to be adequate for octogenarians. The sedative agent of choice for sedation in ERCP seems to be propofol due to its fast distribution and fast elimination time without a cumulative effect after infusion, resulting in shorter recovery time. Its therapeutic spectrum, however, is much narrower and therefore careful monitoring is much more demanding in order to differentiate between moderate, deep sedation and general anesthesia. Apart from conventional monitoring, capnography and Bispectral index or Narcotrend monitoring of the level of sedation seem to be useful in titrating sedatives in ERCP.
PMCID: PMC3055942  PMID: 21403815
Deep sedation; Endoscopic retrograde cholangiopacreatography; Monitoring; Sedatives
6.  Does Level of Sedation Impact Detection of Advanced Neoplasia? 
Digestive diseases and sciences  2010;55(8):10.1007/s10620-010-1226-1.
Background and Aims
Two of the foremost issues in screening colonoscopy involve delivering quality and maximizing adenoma detection rates (ADR). Little is known about the impact of deep sedation on ADR. This study aims to compare the detection of advanced lesions during screening colonoscopy performed with moderate conscious sedation (MCS) versus deep sedation (DS).
A retrospective cohort study was performed using the Clinical Outcomes Research Initiative database. Average risk screening colonoscopies performed January 2000 to December 2005 were examined for practice setting, patient demographics, and findings, including detection of a polyp >9 mm and suspected malignant lesions.
A total of 104,868 colonoscopies were examined, 97% of which were performed with MCS. Univariate analysis demonstrated that more polyps of any size were detected with MCS (38 vs. 34%, p < 0.0001) and more advanced lesions were found with DS compared with MCS (7 vs. 6%, p = 0.01). When exclusively examining sites that performed DS [10% for all procedures, a more significant increase in advanced lesion detection when using DS was observed (7.5 vs. 5.7%, p = 0.003). When adjusted for age, gender, race/ethnicity, site, prep quality, and ASA group, DS was 25% more likely to detect an advanced lesion.
Our data suggest that use of DS may be associated with a higher rate of advanced lesion detection. However, this retrospective design has limitations that necessitate follow-up with prospective studies. These follow-up studies would be essential to support any change in the standard practices of sedation.
PMCID: PMC3846178  PMID: 20411420
Colonoscopy; Deep sedation; Advanced neoplasia; Propofol Polyp
7.  Sedation in gastrointestinal endoscopy: a prospective study comparing nonanesthesiologist-administered propofol and monitored anesthesia care 
Endoscopy International Open  2015;3(1):E7-E13.
Introduction: Adequate sedation is one of the cornerstones of good quality gastrointestinal endoscopy (GIE). Propofol sedation has increased significantly but there has been much debate over whether it can be administered by endoscopists. The aim of this prospective trial was to compare nonanesthesiologist-administered propofol (NAAP) and monitored anesthesia care (MAC).
Methods: A total of 2000 outpatients undergoing GIE at Hospital Albert Einstein (São Paulo, Brazil), a tertiary-care private hospital, were divided into two matched groups: NAAP (n = 1000) and MAC (n = 1000). In NAAP, propofol doses were determined by the endoscopist. A second physician stayed in the room during the entire procedure, according to local regulations. In MAC, the anesthesiologist administered propofol.
Results: In total, 1427 patients (71.3 %) were ASA (American Society of Anesthesiologists) class I and 573 were ASA class II. In NAAP, patients received more propofol + fentanyl (61.1 % vs. 50.5 %; P < 0.05) and there were fewer cases of deep sedation (44.7 % vs. 66.1 %; P < 0.05). Hypoxemia rates were similar (12.8 % for NAAP and 11.2 % for MAC; P = 0.3) but these reverted more rapidly in MAC (4.22 seconds vs. 7.26 seconds; P < 0.05). Agitation was more frequent in MAC (14.0 % vs. 5.6 %; P < 0.05). No later complications were observed. Patient satisfaction was very high and similar in both groups.
Conclusion: In this setting, NAAP was as safe and effective as MAC for healthy patients undergoing GIE.
Clinical trial ref. no.: U1111-1134-4430
PMCID: PMC4423250  PMID: 26134777
8.  The effect of interruption to propofol sedation on auditory event-related potentials and electroencephalogram in intensive care patients 
Critical Care  2004;8(6):R483-R490.
In this observational pilot study we evaluated the electroencephalogram (EEG) and auditory event-related potentials (ERPs) before and after discontinuation of propofol sedation in neurologically intact intensive care patients.
Nineteen intensive care unit patients received a propofol infusion in accordance with a sedation protocol. The EEG signal and the ERPs were measured at the frontal region (Fz) and central region (Cz), both during propofol sedation and after cessation of infusion when the sedative effects had subsided. The EEG signal was subjected to power spectral estimation, and the total root mean squared power and spectral edge frequency 95% were computed. For ERPs, we used an oddball paradigm to obtain the N100 and the mismatch negativity components.
Despite considerable individual variability, the root mean squared power at Cz and Fz (P = 0.004 and P = 0.005, respectively) and the amplitude of the N100 component in response to the standard stimulus at Fz (P = 0.022) increased significantly after interruption to sedation. The amplitude of the N100 component (at Cz and Fz) was the only parameter that differed between sedation levels during propofol sedation (deep versus moderate versus light sedation: P = 0.016 and P = 0.008 for Cz and Fz, respectively). None of the computed parameters correlated with duration of propofol infusion.
Our findings suggest that use of ERPs, especially the N100 potential, may help to differentiate between levels of sedation. Thus, they may represent a useful complement to clinical sedation scales in the monitoring of sedation status over time in a heterogeneous group of neurologically intact intensive care patients.
PMCID: PMC1065074  PMID: 15566595
electroencephalogram; event-related potentials; intensive care; propofol; sedation
9.  Outpatient endoscopic retrograde cholangiopancreatography: Safety and efficacy of anesthetic management with a natural airway in 653 consecutive procedures 
Saudi Journal of Anaesthesia  2013;7(3):259-265.
Endoscopic retrograde cholangiopancreatography (ERCP) is a unique diagnostic and therapeutic procedure performed in high risk patients in prone/semi-prone position. Propofol based deep sedation has emerged as the method of choice however, the ability to predict possible complications is yet un-explored.
The present study aimed to evaluate known high risk-factors for general anesthesia (American Society of Anesthesiologists (ASA) status, body mass index (BMI), and Mallampati class) for their ability to affect outcomes in ERCP patients.
Study Design:
Retrospective data of 653 patients who underwent ERCP during a period of 26 months at university hospital of Pennsylvania was reviewed. Patient-specific and procedure specific data was extracted. Desaturation was defined by fall of pulse oximeter saturation below 95% and its relation to patient specific high risk-factors was analyzed.
Only 45 patients had transient de-saturation below 95% without any residual sequlae. No statistically significant relation between desaturation episodes and patients higher ASA status or BMI or modified Mallampati (MMP) class was found. Despite 60% patients being ASA III/IV none required emergency intubation or procedural interruption. Optimal oxygenation and airway patency was maintained with high degree of success using simple airway maneuvers or conduit devices (nasal/oral trumpet) with oxygen supplementation in all patients.
Unlike general anesthesia, pre-operative patient ASA status, higher MMP or increasing BMI does not bear relation with likelihood of patients desaturating during ERCP. In presence of vigilant apnea monitoring and careful dose titration of maintenance anesthetics with airway conduits, general anesthesia, emergency intubations, and procedure interruptions can be avoided.
PMCID: PMC3757797  PMID: 24015127
Airway in endoscopic retrograde cholangiopancreatography; endoscopic retrograde cholangiopancreatography anesthesia; endoscopic retrograde cholangiopancreatography desaturation; risk predictors endoscopic retrograde cholangiopancreatography
10.  Sedation-related complications in gastrointestinal endoscopy 
Sedation practices for gastrointestinal endoscopic (GIE) procedures vary widely in different countries depending on health system regulations and local circumstances. The goal of procedural sedation is the safe and effective control of pain and anxiety, as well as to provide an appropriate degree of memory loss or decreased awareness. Sedation-related complications in gastrointestinal endoscopy, once occurred, can lead to significant morbidity and occasional mortality in patients. The risk factors of these complications include the type, dose and mode of administration of sedative agents, as well as the patient’s age and underlying medical diseases. Complications attributed to moderate and deep sedation levels are more often associated with cardiovascular and respiratory systems. However, sedation-related complications during GIE procedures are commonly transient and of a mild degree. The risk for these complications while providing any level of sedation is greatest when caring for patients already medically compromised. Significant unwanted complications can generally be prevented by careful pre-procedure assessment and preparation, appropriate monitoring and support, as well as post-procedure management. Additionally, physicians must be prepared to manage these complications. This article will review sedation-related complications during moderate and deep sedation for GIE procedures and also address their appropriate management.
PMCID: PMC3831194  PMID: 24255744
Sedation; Complication; Gastrointestinal; Endoscopy
11.  Comparison of Electrophysiologic Monitors With Clinical Assessment of Level of Sedation 
OBJECTIVE: To assess the correlation between 2 clinical sedation scales and 2 electroencephalographic (EEG)–based monitors used during surgical procedures that required mild to moderate sedation.
PATIENTS AND METHODS: Patients scheduled for elective surgery participated in this institutional review board–approved study from March 2003 to February 2004. Level of sedation was determined both clinically using the Ramsay and the Observer's Assessment of Alertness/Sedation scales and with 2 EEG measures (the Bispectral Index version XP [BIS XP] or the Patient State Analyzer [PSA 4000]). Correlation between these 2 measures of sedation were tested using nonparametric statistical tests.
RESULTS: The BIS XP monitor was used in 26 patients, and the PSA 4000 monitor was used in 24 patients. The Ramsay and Observer's Assessment of Alertness/Sedation scores correlated with each other (r=−0.96; P<.001) and with both the BIS XP (r=−0.89 and r=0.91, respectively; P<.001) and the PSA 4000 (r=−0.80 and r=0.80, respectively; P<.001) values. However, this correlation was strongest only at the extremes. Between the BIS XP and PSA 4000 values of 61 and 80, the clinical sedation scores varied greatly.
CONCLUSION: On the basis of our results, these EEG-based monitors cannot reliably distinguish between light and deep sedation.
PMCID: PMC1413967  PMID: 16438478
12.  Anesthesia for ERCP: Impact of Anesthesiologist's Experience on Outcome and Cost 
The present study evaluates the effect of anesthesiologist's experience in providing deep sedation for endoscopic retrograde cholangiopancreatography (ERCP) on cost and safety. Methodology. Perioperative records of 1167 patients who underwent ERCP were divided on the basis of anesthesiologist assisting these procedures either on regular basis (Group R) or on ad hoc basis (Group N). Comparisons were made for anesthesia times, complication rates, and airway interventions. Results. Across all American Society of Anesthesiologists (ASA) Classes, regular anesthesiologists were more efficient (overall mean anesthesia time in Group R was 24.82 ± 12.96 versus 48.63 ± 21.53 minutes in Group N). Within Group R, anesthesia times across all ASA classes were comparable. In Group N, anesthesia times for higher ASA status patients were significantly longer (ASA IV, 64.62 ± 35.78 versus ASA I, 45.88 ± 11.19 minutes). Intubation rates (0.76% versus 12.8%) and median minimal oxygen saturation (100% versus 97.01%) were significantly higher in Group R. Had Group R anesthesiologists performed all procedures, the hospital could have saved US $ 758536 (based upon operating room time costs). Conclusion. Experience in providing deep sedation improved patient safety and decreased the operating room turnaround time, thereby lowering operating room costs associated with these procedures.
PMCID: PMC3679699  PMID: 23781243
13.  Difficult colonoscopies in the propofol era 
BMC Surgery  2012;12(Suppl 1):S9.
To study the relationship between endoscopic practice and adverse events during colonoscopy under standard deep sedation induced and monitored by an anesthetist.
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.
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.
PMCID: PMC3499204  PMID: 23173918
14.  Delirium, Sedation and Analgesia in the Intensive Care Unit: A Multinational, Two-Part Survey among Intensivists 
PLoS ONE  2014;9(11):e110935.
Analgesia, sedation and delirium management are important parts of intensive care treatment as they are relevant for patients' clinical and functional long-term outcome. Previous surveys showed that despite this fact implementation rates are still low. The primary aim of the prospective, observational multicenter study was to investigate the implementation rate of delirium monitoring among intensivists. Secondly, current practice concerning analgesia and sedation monitoring as well as treatment strategies for patients with delirium were assesed. In addition, this study compares perceived and actual practice regarding delirium, sedation and analgesia management. Data were obtained with a two-part, anonymous survey, containing general data from intensive care units in a first part and data referring to individual patients in a second part. Questionnaires from 101 hospitals (part 1) and 868 patients (part 2) were included in data analysis. Fifty-six percent of the intensive care units reported to monitor for delirium in clinical routine. Fourty-four percent reported the use of a validated delirium score. In this respect, the survey suggests an increasing use of delirium assessment tools compared to previous surveys. Nevertheless, part two of the survey revealed that in actual practice 73% of included patients were not monitored with a validated score. Furthermore, we observed a trend towards moderate or deep sedation which is contradicting to guideline-recommendations. Every fifth patient was suffering from pain. The implementation rate of adequate pain-assessment tools for mechanically ventilated and sedated patients was low (30%). In conclusion, further efforts are necessary to implement guideline recommendations into clinical practice. The study was registered ( identifier: NCT01278524) and approved by the ethical committee.
PMCID: PMC4232258  PMID: 25398099
15.  Bispectral index versus COMFORT score to determine the level of sedation in paediatric intensive care unit patients: a prospective study 
Critical Care  2004;9(1):R9-R17.
Most clinicians give sedatives and analgesics according to their professional experience and the patient's estimated need for sedation. However, this approach is prone to error. Inadequate monitoring of sedation and analgesia may contribute to adverse outcomes and complications. With this in mind, data obtained continuously using nonstimulating methods such as bispectral index (BIS) may have benefits in comparison with clinical monitoring of sedation. The aim of this prospective observational trial was to evaluate the use of electroencephalographic (EEG) BIS for monitoring sedation in paediatric intensive care unit (PICU) patients.
Forty paediatric patients (<18 years) were sedated for mechanical ventilation in a cardiac surgical and general PICU. In each paediatric patient BIS and COMFORT score were obtained. The study protocol did not influence ongoing PICU therapy. BIS and corresponding COMFORT score were collected three times for each patient. Measurements with the best starting EEG impedances were analyzed further. Deep sedation was defined as a COMFORT score between 8 and 16, and light sedation as a score between 17 and 26. Biometric and physiological data, and Pediatric Risk of Mortality III scores were also recorded.
There was a good correlation (Spearman's rho 0.651; P = 0.001) between BIS and COMFORT score in the presence of deep sedation and low starting impedance. Receiver operating characteristic (ROC) analysis revealed best discrimination between deep and light sedation at a BIS level of 83.
In the presence of deep sedation, BIS correlated satisfactorily with COMFORT score results if low EEG impedances were guaranteed.
PMCID: PMC1065097  PMID: 15693968
bispectral index; electroencephalography; intensive care unit; paediatric; sedation
16.  Nitrous Oxide Sedation and Bispectral Index 
European journal of dentistry  2007;1(4):240-245.
To determine whether bispectral analysis (BIS) changes during nitrous oxide (N2O) sedation in anxious children undergoing extraction of primary teeth.
In this prospective study 45, ASA physical status I children, aged between 7 to 12 years and scheduled for primary teeth extraction under N2O/O2 sedation are included. At baseline (T0) and during the sedation procedure (T1-6); BIS levels, Ramsay Sedation Scores (RSS), oxygen saturation (Sp02), and heart rate (HR) were recorded at one-minute intervals. Forty percent N2O in O2 was given by a nasal hood, and N2O concentration was enhanced to 60% in a two-minute period. Paired measurements of BIS levels with Observer’s Assessment of Alertness and Sedation (OAA/S) scores were obtained during sedation procedure.
Since 5 patients refused application of the nasal hood, a total 40 of the original 45 subjects completed the study. Mean age and weight of the children were 9.5 ± 1.4 years and 23.7 ± 9.7 kg, respectively. Nitrous oxide inhalation produced no changes in BIS levels despite a sedation level in OAA/S scores were observed at 40–60% N2O concentrations.
BIS values do not change during N2O/O2 sedation and the BIS monitor is not appropriate to evaluate the depth of sedation provided by N2O/O2 during primary teeth extraction in children.
PMCID: PMC2609910  PMID: 19212474
Nitrous oxide sedation; Bispectral index; Anxiety; Ramsay sedation scale
17.  Retrospective Outcomes Evaluation of 100 Parenteral Moderate and Deep Sedations Conducted in a General Practice Dental Residency 
Anesthesia Progress  2008;55(4):116-120.
An abstract of this study was presented at the American Association for Dental Research (AADR) Dental Anesthesiology Research Group in Honolulu, Hawaii, in March of 2004. This study was conducted to correlate the intraoperative and postoperative morbidity associated with moderate and deep sedation, also known as monitored anesthesia care (MAC), provided in a General Practice Residency (GPR) clinic under the supervision of a dentist anesthesiologist. After internal review board approval was obtained, 100 parenteral moderate and deep sedation cases performed by the same dentist anesthesiologist in collaboration with second year GPR residents were randomly selected and reviewed by 2 independent evaluators. Eleven morbidity criteria were assessed and were correlated with patient age, gender, American Society of Anesthesiology Physical Status Classification (ASAPS), duration of procedure, and anesthetic protocol. A total of 39 males and 61 females were evaluated. Patients' ASAPS were classified as I, II, and III, with the average ASAPS of 1.61 and the standard deviation (STDEV) of 0.584. No ASPS IV or V was noted. Average patient age was 33.8 years (STDEV, 14.57), and the average duration of procedure was 97.5 minutes (STDEV, 42.39). Three incidents of postoperative nausea and vomiting were reported. All 3 incidents involved the ketamine-midazolam-propofol anesthetic combination. All patients were treated and were well controlled with ondansetron. One incident of tongue biting in an autistic child was regarded as an effect of local anesthesia. One patient demonstrated intermittent premature atrial contractions (PACs) intraoperatively but was stable. Moderate and deep sedation, also known as MAC, is safe and beneficial in an outpatient GPR setting with proper personnel and monitoring. This study did not demonstrate a correlation between length of procedure and morbidity. Ketamine was associated with all reported nausea and vomiting incidents because propofol and midazolam are rarely associated with such events.
PMCID: PMC2614649  PMID: 19108595
Dental sedation; Sedation training; Sedation outcomes
18.  A target-controlled infusion system with bispectral index monitoring of propofol sedation during endoscopic submucosal dissection 
Endoscopy International Open  2014;3(1):E2-E6.
Background and study aims: Propofol administration via a target-controlled infusion system with bispectral index monitoring (BIS/TCI system) is expected to prevent complications from sedation during complex and long endoscopic procedures. We evaluated the feasibility of setting the BIS/TCI system for non-anesthesiologist administration of propofol (NAAP) during endoscopic submucosal dissection (ESD).
Patients and methods: From May 2009 to February 2013, 250 patients with esophagogastric neoplasms were treated with ESD using the BIS/TCI system with NAAP. In the TCI system, the initial target blood concentration of propofol was set at 1.2 μg/mL. The titration speed of propofol was adjusted according to the BIS score and the movement of the patient. The BIS target level ranged from moderate to deep sedation, at which a stable BIS score between 60 and 80 was obtained.
Results: In 80.4 % of patients, it was possible to maintain stable sedation with a blood concentration of propofol of less than 1.6 µg/mL using TCI throughout the ESD procedure. The default setting for ideal blood concentration of propofol was 1.2 μg/mL, because the medians of the lower and upper bounds of blood concentration were 1.2 μg/mL (range 0.6 – 1.8 μg/mL) and 1.4 μg/mL (range 1.0 – 3.8 μg/mL), respectively. Although hypotension occurred in 27 patients (10.8 %), oxygen desaturation occurred in only nine patients (3.6 %), and severe desaturation in only two patients (0.8 %).
Conclusions: Using our settings, it is possible for a non-anesthesiologist to maintain stable sedation during a lengthy endoscopic procedure through propofol sedation with a BIS/TCI system.
PMCID: PMC4423246  PMID: 26134767
19.  A randomized controlled proof-of-concept trial of early sedation management using Responsiveness Index monitoring in mechanically ventilated critically ill patients 
Critical Care  2015;19(1):333.
Deep sedation is associated with adverse patient outcomes. We recently described a novel sedation-monitoring technology, the Responsiveness Index (RI), which quantifies patient arousal using processed frontal facial EMG data. We explored the potential effectiveness and safety of continuous RI monitoring during early intensive care unit (ICU) care as a nurse decision-support tool.
In a parallel-group controlled single centre proof of concept trial, patients requiring mechanical ventilation and sedation were randomized via sequential sealed envelopes following ICU admission. Control group patients received hourly clinical sedation assessment and daily sedation holds; the RI monitor was connected but data were concealed from clinical staff. The intervention group received control group care, but RI monitoring was visible and nurses were asked to adjust sedation to maintain patients with an RI>20 whenever possible. Traffic-light colour coding (RI<20, Red; 20–40, Amber; >40, Green) simplified decision-making. The intervention lasted up to 48 hours. Sixteen nurses were interviewed to explore their views of the novel technology.
We analysed 74 patients treated per protocol (36 intervention; 38 control). The proportion of patients with RI<20 was identical at the start of monitoring (54 % both groups). Overall, the proportion of time with RI<20 trended to lower values for the intervention group (median 16 % (1–3rd quartile 8–30 %) versus 33 % (10–54 %); P = 0.08); sedation and analgesic use was similar. A post hoc analysis restricted to patients with RI<20 when monitoring started, found intervention patients spent less time with low RI value (16 % (11–45 %) versus 51 % (33–72 %); P = 0.02), cumulative propofol use trended to lower values (median 1090 mg versus 2390 mg; P = 0.14), and cumulative alfentanil use was lower (21.2 mg versus 32.3 mg; P = 0.01). RASS scores were similar for both groups. Sedation related adverse event rates were similar (7/36 versus 5/38). Similar proportions of patients had sedation holds (83 % versus 87 %) and were extubated (47 % versus 44 %) during the intervention period. Nurses valued the objective visible data trends and simple colour prompts, and found RI monitoring a useful adjunct to existing practice.
RI monitoring was safe and acceptable. Data suggested potential to modify sedation decision-making. Larger trials are justified to explore effects on patient-centred outcomes.
Trial registration
NCT01361230 (registered April 19, 2010)
Electronic supplementary material
The online version of this article (doi:10.1186/s13054-015-1043-1) contains supplementary material, which is available to authorized users.
PMCID: PMC4570737  PMID: 26370687
20.  Spectral entropy for assessing the depth of propofol sedation 
Korean Journal of Anesthesiology  2012;62(3):234-239.
For patients in the intensive care unit (ICU) or under monitored anesthetic care (MAC), the precise monitoring of sedation depth facilitates the optimization of dosage and prevents adverse complications from underor over-sedation. For this purpose, conventional subjective sedation scales, such as the Observer's Assessment of Alertness/Sedation (OAA/S) or the Ramsay scale, have been widely utilized. Current procedures frequently disturb the patient's comfort and compromise the already well-established sedation. Therefore, reliable objective sedation scales that do not cause disturbances would be beneficial. We aimed to determine whether spectral entropy can be used as a sedation monitor as well as determine its ability to discriminate all levels of propofol-induced sedation during gradual increments of propofol dosage.
In 25 healthy volunteers undergoing general anesthesia, the values of response entropy (RE) and state entropy (SE) corresponding to each OAA/S (5 to 1) were determined. The scores were then analyzed during each 0.5 mcg/ml- incremental increase of a propofol dose.
We observed a reduction of both RE and SE values that correlated with the OAA/S (correlation coefficient of 0.819 in RE-OAA/S and 0.753 in SE-OAA/S). The RE and SE values corresponding to awake (OAA/S score 5), light sedation (OAA/S 3-4) and deep sedation (OAA/S 1-2) displayed differences (P < 0.05).
The results indicate that spectral entropy can be utilized as a reliable objective monitor to determine the depth of propofol-induced sedation.
PMCID: PMC3315652  PMID: 22474549
Entropy; Propofol; Sedation
21.  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.
PMCID: PMC2900045  PMID: 20668560
Conscious sedation; deep sedation; minimal anesthesia; procedural sedation
22.  Predicting native papilla biliary cannulation success using a multinational Endoscopic Retrograde Cholangiopancreatography (ERCP) Quality Network 
BMC Gastroenterology  2013;13:147.
Success in deep biliary cannulation via native ampullae of Vater is an accepted measure of competence in ERCP training and practice, yet prior studies focused on predicting adverse events alone, rather than success. Our aim is to determine factors associated with deep biliary cannulation success, with/ without precut sphincterotomy.
The ERCP Quality Network is a unique prospective database of over 10,000 procedures by over 80 endoscopists over several countries. After data cleaning, and eliminating previously stented or cut papillae, two multilevel fixed effect multivariate models were used to control for clustering within physicians, to predict biliary cannulation success, with and without allowing “precut” to assist an initially failed cannulation.
13018 ERCPs were performed by 85 endoscopists (March 2007 - May 2011). Conventional (without precut) and overall cannulation rates were 89.8% and 95.6%, respectively. Precut was performed in 876 (6.7%). Conventional success was more likely in outpatients (OR 1.21), but less likely in complex contexts (OR 0.59), sicker patients (ASA grade (II, III/V: OR 0.81, 0.77)), teaching cases (OR 0.53), and certain indications (strictures, active pancreatitis). Overall cannulation success (some precut-assisted) was more likely with higher volume endoscopists (> 239/year: OR 2.79), more efficient fluoroscopy practices (OR 1.72), and lower with moderate (versus deeper) sedation (OR 0.67).
Biliary cannulation success appears influenced by both patient and practitioner factors. Patient- and case-specific factors have greater impact on conventional (precut-free) cannulation success, but volume influences ultimate success; both may be used to select appropriate cases and can help guide credentialing policies.
PMCID: PMC3882886  PMID: 24112846
23.  The use of bispectral index monitors in paediatric intensive care 
Critical Care  2004;9(1):25-26.
The bispectral index (BIS) is a processed neurophysiological electroencephalographic parameter that may be used to evaluate the depth of sedation in critically ill children. Triltsch and colleagues attempted to correlate BIS scores with a commonly used clinical sedation scoring system. They were able to demonstrate good correlation during deep sedation and in cases where the electrical impedance of the BIS electrodes was lowest. Studies have shown only moderate degrees of correlation between BIS scores and clinical sedation scoring systems. There is currently insufficient evidence to recommend routine monitoring of BIS scores in critically ill children.
PMCID: PMC1065103  PMID: 15693977
bispectral index; neurophysiological; paediatric intensive care unit; sedation
24.  Bispectral Index Monitoring of Sedation Depth in Pediatric Dental Patients 
Anesthesia Progress  2011;58(2):66-72.
The bispectral index (BIS) monitor records electroencephalogram waveforms and provides an objective measure of the hypnotic effect of a sedative drug on brain activity. The aim of this pilot study was to use the BIS monitor to evaluate the depth of procedural sedation in pediatric dental patients and to assess if the BIS monitor readings correlate with a validated pediatric sedation scale, the University of Michigan Sedation Scale (UMSS), in determining the level of sedation in these patients. Thirty-five pediatric dental patients requiring sedation were studied prospectively. A baseline BIS reading was obtained and during the procedure an independent observer recorded the BIS every 5 minutes. The operator, who was blinded to the BIS results, determined the UMSS scale at the same 5-minute interval. The patients were monitored postoperatively for 1 hour. There was a significant but moderate correlation between BIS values and UMSS scores (Spearman's rank correlation r  =  −0.574, P < .0001). Percentage of agreement and kappa coefficient using all the observations were also calculated. The percentage of agreement was 37.8%, the kappa coefficient was 0.18 (P < .0001), and the weighted kappa coefficient 0.26 (P < .0001). A lack of correlation was noted between the deeper levels of UMSS sedation scores and BIS values. This study demonstrated a significant correlation between BIS values and the UMSS score in pediatric dental patients undergoing mild to moderate sedation. Based on our results, it appears that the BIS monitor may be useful during mild or moderate sedations to establish the level of sedation objectively without the need to stimulate the patient.
PMCID: PMC3198129  PMID: 21679042
Bispectral index monitor; Pediatric sedation; University of Michigan Sedation Scale; Pediatric dentistry
25.  Anesthesia and sedation in pediatric gastrointestinal endoscopic procedures: A review 
Gastrointestinal (GI) endoscopic procedure has become an essential modality for evaluation and treatment of GI diseases. Intravenous (IV) sedation and General Anesthesia (GA) have both been employed to minimize discomfort and provide amnesia. Both these procedures require, at the very least, monitoring of the level of consciousness, pulmonary ventilation, oxygenation and hemodynamics. Although GI endoscopy is considered safe, the procedure has a potential for complications. Increased awareness of the complications associated with sedation during GI endoscopy in children, and involving the anesthesiologists in caring for these children, may be optimal for safety. Belonging to a younger age group, having a higher ASA class and undergoing IV sedation were identified as risk factors for developing complications. Reported adverse events included inadequate sedation, low oxygen saturation, airway obstruction, apnea needing bag mask ventilation, excitement and agitation, hemorrhage and perforation. A complication rate of 1.2% was associated with procedures performed under GA, as compared to 3.7% of complications associated with IV sedation. IV sedation was seen to be independently associated with a cardiopulmonary complication rate 5.3% times higher when compared to GA. GA can therefore be considered safer and more effective in providing comfort and amnesia.
PMCID: PMC2999145  PMID: 21160616
Gastrointestinal; Endoscopy; Pediatrics; Sedation; General anesthesia

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