Abstract
Background and aim : Conscious sedation is universally used to reduce patient discomfort, anxiety, and pain during endoscopy, so that the endoscopic procedures can be effectively and safely completed. In Japan, three benzodiazepines, including diazepam, midazolam and flunitrazepam, are approved for intravenous use administer during endoscopy. However, only a few studies have compared these benzodiazepines with respect to their effectiveness and the safety. This study compared the effectiveness, the safety, and recovery time of midazolam and flunitrazepam during diagnostic upper gastrointestinal endoscopy.
Patients and Method : Forty patients were sedated with i.v. midazolam (average dose 2.65 mg : M-Group), and thirty-seven patients were sedated with i.v. flunitrazepam (average dose 0.33 mg : F-Group). After the drug was given, a diagnostic upper gastrointestinal endoscopy was done by one of 5 staff endoscopists. Depth of sedation, vital signs, patient's tolerance, the endoscopic procedure's technical ease and the sedation recovery time were evaluated by one independent observer for all patients.
Results : The two groups were not significantly different with respect to : gender, age, BMI, ASA risk class, experience with previous upper upper gastrointestinal endoscopy, and procedure duration. Depth of sedation evaluated by OAA/S was significantly deeper in the M-Group than in the F-Group, although a moderate sedation level was maintained in both groups. There was no difference in the vital signs, including blood pressure, heart rate, and pulse oximetry between the groups ; as well, no clinical complications were observed in either groups. There were no statistically significant differences between the two groups with respect to the number of excellent technical ease, and the sedation recovery time (about 40 min in the both groups). However, the patient's 100 mm Visual Analogue Scale assessment of tolerance was significantly lower in the M-Group (7.9mm) than in the F-Group (26.8 mm). Complete amnesia of the endoscopic procedure occurred in 55% of the M-Group and 19% of the F-Group.
Conclusion : The safety of midazolam and flunitrazepam was almost the same with respect to vital sign and the sedation recovery time. However, the effectiveness of midazolam including depth of sedation and patients tolerance was significantly better than flunitrazepam. Midazolam caused less discomfort and was more frequently associated with amnesia than flunitrazepam.
