The effect of sedation on the quality of upper GI endoscopy: an investigator blinded randomized study comparing propofol with midazolam

Medical Department II, Technical University of Munich, Munich, Germany.
Endoscopy (Impact Factor: 5.05). 05/2007; 39(4):345-9. DOI: 10.1055/s-2006-945195
Source: PubMed


Sedation with propofol is associated with a high acceptance rate in upper gastrointestinal endoscopy. So far, however, there are no valid data on whether the use of propofol can increase the general quality of the endoscopic examination.
A total of 60 patients referred for upper gastrointestinal endoscopy were randomized to receive sedation with either midazolam (n = 30) or propofol (n = 30). The maximum dosages permitted were 5 mg of midazolam and 500 mg of propofol. The examinations were recorded on videotapes, and the quality of upper endoscopy was assessed by videotape analysis by three experienced endoscopists who were all blinded to patient data and the medications used for sedation. A score sheet was used with 18 assessment items that each represented a step of upper gastrointestinal endoscopy and a global score for the entire examination. A scale ranging from 1 (excellent) to 6 (very poor) was used. Data were analyzed on an intention-to-investigate basis: inability to perform the procedure because of a patient's intolerance of the procedure, for example, was scored as 6 (i. e. very poor).
Patients in the two groups were well matched with respect to demographic and clinical data. Four patients in the midazolam group could not be adequately examined. The median dosage used for sedation was 5 mg midazolam (range 2-5 mg) and 160 mg propofol (range 70-320 mg). When assessments by all three blinded examiners were added together, propofol sedation was found to result in significantly better scores for all parameters except for the assessments of "Z-line/cardia", "duodenal bulb", and "duodenal folds" (all P < 0.05, Mann-Whitney U test).
Sedation with propofol might increase the quality of upper endoscopy. This finding may have a significant impact on the selection of the type of sedation, not only in terms of increasing patients' acceptance of the procedure, but also for improving the diagnostic accuracy of upper gastrointestinal endoscopy.

1 Follower
15 Reads
    • "Intravenous propofol, either alone or with concomitant benzodiazepines or opioids, has generated widespread interest. The quality of sedation is better and recovery time is shorter,[13] but with a narrow therapeutic range.[14] A recent meta-analysis suggests that propofol is as safe as midazolam.[15] "
    [Show abstract] [Hide abstract]
    ABSTRACT: We aimed to study whether sedation reduces discomfort during endoscopy and a comparison of longer-acting diazepam with shorter-acting midazolam. A prospective, randomized, single-blinded study was conducted at the Department of Medicine at Government Medical College and Hospital, Chandigarh, and was completed over a period of 6 months. The patients were randomized to receive either placebo or sedation with midazolam or diazepam before endoscopy. The endoscopist and the observer recording patient's/physician's responses were blinded to the drugs administered. Two hundred and fifty two consecutive patients undergoing diagnostic or therapeutic upper gastrointestinal endoscopy were recruited. The patient's discomfort and the physician's comfort during the procedure were recorded on a visual analogue scale rated from 1-10 with-in 10 minutes of the procedure by an independent observer. The Patient's discomfort ratings were further divided into 3 groups, comfortable (score, 1-3), satisfactory (score, 4-7) and uncomfortable (a score of >7). Similarly the physician's ease of performing the procedure was also recorded on the same scale. This was again divided into 3 groups: easy (score, 1-3), satisfactory (score, 4-7) and difficult (a score of >7). Out of the total of 252 patients, 82 patients received no sedation (group I), 85 received diazepam (group II) and 85 received midazolam (group III). There was no statistical difference in the discomfort experienced by the patients during endoscopy when sedation was used (P=0.0754). Out of 252 patients, 49 underwent endoscopic procedures. Nineteen patients were included in group I, 18 in group II and 12 in group III. Only 10 (20%) patients undergoing endoscopic procedures complained of significant discomfort, but there was no difference in the ones undergoing interventions with or without sedation (P=0.854). The physicians were more comfortable in performing endoscopic procedure in sedated patients, however, the difference between patients in group II and group III was not statistically significant (P=0.0461). Both diazepam and midazolam fared equally well in increasing physician's comfort (P=0.617). There was no difference in the patient's discomfort with regard to the sedative used (midazolam or diazepam). Although endoscopy was easy or satisfactory in the majority of patients in the unsedated as well as the sedated groups, more often the endoscopist found it difficult to do endoscopy on the unsedated patients.
    Saudi Journal of Gastroenterology 10/2010; 16(4):280-4. DOI:10.4103/1319-3767.70616 · 1.12 Impact Factor
  • Source
    • "midazolam [2]) propofol (2, 6 diisopropyl phenol), an ultra short-acting hypnotic agent, has emerged as a possibly superior alternative [3,4]. Thus, propofol simplified the technical performance of colonoscopy [5] and increased the quality of upper endoscopy in comparison to midazolam [6]. Propofol sedation also has the advantage of a shortened recovery time [1,7]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Although gastrointestinal endoscopy with sedation is increasingly performed in elderly patients, data on combined sedation with midazolam/propofol are very limited for this age group. We retrospectively analyzed 454 endoscopic procedures in 347 hospitalized patients >or= 70 years who had received combined sedation with midazolam/propofol. 513 endoscopic procedures in 397 hospitalized patients < 70 years during the observation period served as controls. Characteristics of endoscopic procedures, co-morbidity, complications and mortality were compared. Elderly patients had a higher level of co-morbidity and needed lower mean propofol doses for sedation. We observed no major complication and no difference in the number of minor complications. The procedure-associated mortality was 0%; the 28-day mortality was significantly higher in the elderly (2.9% vs. 1.0%). In this study on elderly patients with high level co-morbidity, a favourable safety profile was observed for a combined sedation with midazolam/propofol with a higher sensitivity to propofol in the elderly.
    BMC Gastroenterology 01/2010; 10(1):11. DOI:10.1186/1471-230X-10-11 · 2.37 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: During middle-ear-surgery under local anaesthesia (MES-LA), patients report hearing noises, feeling anxious, and experiencing earache. In a prospective randomized clinical trial, we compared propofol and midazolam for sedation in 68 patients scheduled for MES-LA. The starting dose of propofol was 1 to 1.5 mg per kilogram intravenously, followed by 1 to 2 mg per kilogram per hour given by infusion. The starting dose of midazolam was 0.02 to 0.05 mg per kilogram intravenously, followed by 0.01 to 0.02 mg per kilogram intravenously. Metamizol and fentanyl were added when required. Sedation was titrated to a Ramsay score of 3 to 4 and a bispectral index value of 70 to 80. Patients were assessed for vital parameters and sedation and pain scores. In the recovery room, readiness for discharge and satisfaction of both patient and surgeon with the procedure were assessed. The group receiving propofol had a significantly lower heart rate, shorter duration of sedation, and earlier readiness for discharge (p<0.05). There were no significant differences in other parameters evaluated. Seventy-nine per cent of patients in the group receiving propofol and 91.1% receiving midazolam would choose the same method of anaesthesia and sedation for any further MES-LA. Our results suggest that, compared to midazolam, propofol is more suitable for sedation in patients undergoing MES-LA. However, appropriate patient selection, adequate preparation, and careful monitoring are mandatory.
    Central European Journal of Medicine 12/2008; 3(4):487-493. DOI:10.2478/s11536-008-0069-z · 0.15 Impact Factor
Show more