Moderate sedation for elective upper endoscopy with balanced propofol versus fentanyl and midazolam alone: a randomized clinical trial.

BACKGROUND AND STUDY AIMS: Balanced propofol sedation (BPS) combines propofol with opiates and benzodiazepines and targets at moderate sedation. Data comparing outcomes of BPS and standard sedation with opiates and benzodiazepines during elective esophagogastroduodenoscopy (EGD) are sparse. The primary end point of this study was to compare, in the recovery area, patient satisfaction with EGD following BPS versus standard sedation. PATIENTS AND METHODS: Prospective, single-blinded randomized trial in 110 outpatients undergoing elective EGD and randomized 1:1 to BPS or standard sedation. Upon full recovery, the primary outcome of patient satisfaction was assessed using a 100-mm visual analogue scale (VAS) (1 = not at all satisfied, 100 = completely satisfied). Sedation recovery times and recall of pain and gagging (1 = none, 100 = severe) were also evaluated using a VAS. RESULTS: The BPS and standard sedation groups were similar regarding American Society of Anesthesiologists (ASA), Mallampati class, age, sex, and body mass index (BMI). Compared with the standard sedation arm, the BPS group exhibited higher median procedural satisfaction (99 vs. 85, P < 0.001), and lower median scores for recall of pain (P < 0.001) and gagging (P < 0.001). BPS resulted in a shorter median recovery time (min) (11 vs. 23, P < 0.001). On multivariable regression analysis, predictors of patient satisfaction included use of propofol, increased age, and higher fentanyl dosage. CONCLUSIONS: BPS targeted to moderate sedation by adequately trained endoscopists results in superior patient satisfaction and shorter recovery times than standard sedation alone during EGD.

Sedation in digestive endoscopy: the Athens international position statements.

BACKGROUND: Guidelines and practice standards for sedation in endoscopy have been developed by various national professional societies. No attempt has been made to assess consensus among internationally recognized experts in this field. AIM: To identify areas of consensus and dissent among international experts on a broad range of issues pertaining to the practice of sedation in digestive endoscopy. METHODS: Thirty-two position statements were reviewed during a 1 (1/2)-day meeting. Thirty-two individuals from 12 countries and four continents, representing the fields of gastroenterology, anaesthesiology and medical jurisprudence heard evidence-based presentations on each statement. Level of agreement among the experts for each statement was determined by an open poll. RESULTS: The principle recommendations included the following: (i) sedation improves patient tolerance and compliance for endoscopy, (ii) whenever possible, patients undergoing endoscopy should be offered the option of having the procedure either with or without sedation, (iii) monitoring of vital signs as well as the levels of consciousness and pain/discomfort should be performed routinely during endoscopy, and (iv) endoscopists and nurses with appropriate training can safely and effectively administer propofol to low-risk patients undergoing endoscopic procedures. CONCLUSIONS: While the standards of practice vary from country to country, there was broad agreement among participants regarding most issues pertaining to sedation during endoscopy.

Sedation by non-anesthesiologists: are opioids and benzodiazepines outdated?

At least 3 systematic reviews have assessed the safety of propofol versus traditional agents used for sedation in gastrointestinal endoscopic procedures. These reviews uncovered a marked variability in study design and found the quality of the included randomized controlled trials to be poor. To date there is no demonstrated difference in the endoscopic safety or efficacy of propofol sedation compared to sedation with benzodiazepine with or without an opioid. However, a trend towards reduced complications and higher levels of satisfaction and cost-effectiveness with propofol during colonoscopies, and higher levels of patient satisfaction and improved efficacy may also be expected by using propofol during upper gastrointestinal endoscopies.

Computer-assisted propofol administration.

The use of propofol for sedation in endoscopy may allow for better quality of sedation, quicker recovery and facilitate greater throughput in endoscopy units. The cost-effectiveness and utility of propofol sedation for endoscopic procedures is contingent on the personnel and resources required to carry out the procedure. Computer-based platforms are based on the patients response to stimulation and physiologic parameters. They offer an appealing means of delivering safe and effective doses of propofol. One such means is the bispectral index where continuous EEG recordings are used to assess the degree of sedation. Another is the closed-loop target-controlled system where a set of physical parameters, such as muscle relaxation and auditory-evoked potential, determine a level of medication appropriate to achieve sedation. Patient-controlled platforms may also be used. These electronic adjuncts may help endoscopists who wish to adopt propofol sedation to change current practices with greater confidence.

Prospective comparison of radial and linear endoscopic ultrasound for diagnosis of chronic pancreatitis.

BACKGROUND AND STUDY AIMS: Linear endoscopic ultrasonography (EUS) is currently favored by many endosonographers for the evaluation of pancreatic pathology. However, radial EUS was used in early studies validating EUS for chronic pancreatitis. Radial and linear EUS have never been compared for the diagnosis of chronic pancreatitis. The aim of this study was to compare radial and linear EUS for the diagnosis of chronic pancreatitis using the secretin-stimulated endoscopic pancreatic function test (ePFT) as the reference standard. PATIENTS AND METHODS: One hundred consecutive patients evaluated for pain of possible pancreatic origin underwent combined radial EUS, linear EUS, and secretin ePFT during a single endoscopic session. EUS images were acquired on videotape and blindly scored by three reviewers. The main outcome measure was diagnostic accuracy. RESULTS: The accuracy of radial EUS and linear EUS (cutpoint > or = 4 criteria) was 84 % and 74 %, respectively. The statistical test for noninferiority was significant ( P < 0.001) suggesting that the accuracy of radial EUS is as good as or superior to linear EUS. The ratio of accuracy (pi (radial)/pi (linear)) was 1.14 (95 % confidence interval [CI] 0.99 to 1.28). No statistically significant differences were found between radial and linear EUS in terms of sensitivity, specificity, or overall discriminative ability (area under receiver operating characteristic curve 0.84 vs. 0.76, P = 0.10). Interobserver variability was similar for radial (Fleiss' kappa = 0.61, 95 %CI 0.43 to 0.79) and linear EUS (kappa = 0.50, 95 %CI 0.28 to 0.72). CONCLUSIONS: The accuracy of radial EUS is as good as linear EUS for the diagnosis of chronic pancreatitis.

Risk factors for cardiopulmonary events during propofol-mediated upper endoscopy and colonoscopy.

BACKGROUND: Propofol-mediated sedation for endoscopy is popular because of its rapid onset and recovery profile. AIM: To examine procedure-specific occurrence and risk factors for cardiopulmonary events during propofol-mediated upper endoscopy (EGD) and colonoscopy. DESIGN: A cohort study using the Clinical Outcomes Research Initiative database was used to determine the frequency of cardiopulmonary events. Clinical Outcomes Research Initiative consisted of 69 practice sites comprising 593 US endoscopists. Multivariate logistic regression analysis used variables, such as age, ASA classification and propofol administration by monitored anaesthesia care or gastroenterologist-administered propofol to determine the risk of cardiopulmonary events. RESULTS: The overall cardiopulmonary event rate for 5928 EGDs and 11 683 colonoscopies was 11.7/1000 cases. For colonoscopy, ascending ASA classification was associated with an increased risk. Monitored anaesthesia care was associated with a decreased adjusted relative risk (0.5, 95% CI: 0.36-0.72). ASA I and II patients receiving monitored anaesthesia care for EGD exhibited a significantly lower relative risk (ARR 0.29, 95% CI: 0.14-0.64). For subjects with ASA class III or greater, there was no difference in the risk between monitored anaesthesia care and gastroenterologist-administered propofol. CONCLUSIONS: There are procedure-specific risk factors for cardiopulmonary events during propofol-mediated EGD and colonoscopy. These should be taken into account during future prospective comparative trials.

A randomized prospective trial comparing unsedated esophagoscopy via transnasal and transoral routes using a 4-mm video endoscope with conventional endoscopy with sedation.

BACKGROUND AND STUDY AIMS: Unsedated upper endoscopy is an attractive alternative to conventional sedated endoscopy because it can reduce the cost, complications, and recovery time of the procedure. However, it has not gained widespread acceptance in the United States. A prototype 4-mm-diameter video esophagoscope is available. Our aims were to compare unsedated esophagoscopy using this 4-mm esophagoscope with conventional sedated endoscopy with regard to diagnostic accuracy and patient tolerance, to determine the optimal intubation route (transnasal vs. transoral), and to identify the predictors of tolerance of unsedated endoscopy. PATIENTS AND METHODS: Outpatients presenting for conventional endoscopy were randomized to undergo unsedated esophagoscopy by either the transnasal or the transoral route, followed by conventional endoscopy. The diagnostic findings, optical quality, and patient tolerance scores were assessed. RESULTS: A total of 137 patients were approached and 90 (65.6 %) were randomized to undergo esophagoscopy by the transnasal route (n = 44) or by the transoral route (n = 46) before undergoing conventional esophagoscopy. Patient tolerance of unsedated esophagoscopy was comparable to that of conventional endoscopy. The transnasal route was better tolerated than the transoral route, except with respect to pain, and 93.2 % in transnasal group and 91.3 % in transoral group were willing to have the procedure again. The diagnostic accuracy of endoscopy using the 4-mm video endoscope was similar to that of standard endoscopy. Patients who tolerated the procedure well had lower preprocedure anxiety scores (29 vs. 42.5, P = 0.021) and a higher body mass index (31.5 kg/m2 vs. 28 kg/m2, P = 0.029) than the other patients. CONCLUSIONS: Unsedated esophagoscopy with a 4-mm esophagoscope was well tolerated and has a level of diagnostic accuracy comparable to that of conventional endoscopy. Factors associated with good tolerance of unsedated esophagoscopy were low anxiety levels, high body mass index, and use of the transnasal route. Unsedated endoscopy may be offered to a selected group of patients based on these criteria.

A randomized, double blind study of interleukin 10 for the prevention of ERCP-induced pancreatitis.

OBJECTIVES: Inflammatory cytokines are released during acute pancreatitis. Interleukin 10 (IL-10) is a potent antiinflammatory cytokine with immunosuppressive and antiinflammatory activities. IL-10 has been shown to attenuate pancreatitis in an animal model. A double blind, placebo-controlled pilot study was conducted to evaluate the safety and efficacy of low dose IL-10 for the prevention of ERCP-induced pancreatitis. METHODS: Patients were randomized to receive a single i.v. dose of recombinant human IL-10 (8 microg/kg) or a placebo i.v. bolus injection 15 min before the procedure. Pancreatitis was defined as abdominal pain radiating to the back associated with elevated amylase or lipase two or more times the upper limit of normal requiring hospitalization for > or =2 days. Severity of pancreatitis was based on days of hospitalization. RESULTS: Two hundred patients were enrolled (101 IL-10, 99 placebo). No difference in age, gender, degree of pancreatic duct filling, therapeutic intervention, or complication was detected between the two groups. Eleven patients in the IL-10 group and nine patients in the placebo group had pancreatitis (p = 0.65). The median length of hospitalization was 4 days in the IL-10 group and 3 days in the placebo group (p = 0.75). CONCLUSIONS: IL-10 at the 8-microg/kg i.v. dose was not effective in reducing the incidence or severity of ERCP-induced pancreatitis. Further investigations are necessary to determine if manipulation of the cytokine pathway can prevent ERCP-induced pancreatitis.