Objective: A combination of midazolam and opioid is usually used to achieve conscious sedation and analgesia during colonoscopy, but many patients may tolerate the procedure well without any sedation. This randomized trial aimed to compare the efficacy and recovery time of 3 different regimens consisting of (a) midazolam plus meperidine (b) midazolam plus fentanyl and (c) placebo. The endoscopists’ and patients’ satisfaction was assessed by an appropriate questionnaire. Methods: A total 248 consecutive, unselected patients attending outpatient colonoscopy at a University Hospital were enrolled with informed consent and were randomized to receive (a) midazolam with meperidine [group A] (b) midazolam with fentanyl [group B] or (c) placebo [group C]. Data for procedure times, perceived patient’s discomfort (using a relative patient questionnaire) and physician’s satisfaction from the procedure were collected. Patients and all endoscopy staff directly involved with the procedure except the research nurse were blinded to the regimens used. Results: The mean age of the patients was 58 ± 15 years (range 19–85 years) and 130 were males. The completion rate and time to reach cecum did not differ among the three groups. The recovery time was significantly shorter in group C (placebo, 10.4 ± 2.9 min) compared to the other groups (p < 0.000), but it was also shorter in group B (midazolam plus fentanyl, 43.0 ± 9.3 min) compared to group A (midazolam plus pethidine, 50.1 ± 9.0 min) (p = 0.001). Patients of group B (midazolam plus fentanyl) experienced less pain and discomfort than patients of group A (midazolam plus meperidine) (p = 0.02) and patients of group A experienced less pain than patients of group C (placebo). Many more patients in group B were extremely or very satisfied by the procedure(86.7%) compared to group A (59.7%) and group C (44.5%) (p = 0.001). Adverse events were mild in all groups and slightly less in group B. Conclusions: Sedation with midazolam and fentanyl was more effective, better tolerated and led to slightly faster recovery time than sedation with midazolam and meperidine. According to our findings and the literature, the most appropriate regimen for conscious sedation during colonoscopy is the combination of midazolam and fentanyl. However, both sedation regimens were proven to be effective and safe and even a significant proportion of unsedated patients could tolerate the procedure fairly well.
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