Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation during Endoscopic Submucosal Dissection: A Prospective, Randomized Controlled Study

BACKGROUND/AIMS: Propofol induced sedation with bispectral index (BIS) monitoring has been reported to lead to higher satisfaction in patients and endoscopists during endoscopic submucosal dissection (ESD) procedures. There are no data, however, regarding the efficacy of midazolam and meperidine (M/M) induced sedation with BIS monitoring during ESD. The purpose of this study was to evaluate whether M/M induced sedation with BIS monitoring could improve satisfaction and reduce the dose of M/M required during ESD. METHODS: Between September 2009 and January 2010, 56 patients were prospectively enrolled and randomly assigned to a BIS group (n=28) and a non-BIS group (n=28). Patient and endoscopist satisfaction scores were assessed using the visual analog scale (0 to 100) following the ESD. RESULTS: The mean satisfaction scores did not significantly differ between the BIS and non-BIS groups (92.3±16.3 vs 93.3±15.5, p=0.53) or endoscopists (83.1±15.4 vs 80.0±16.7, p=0.52). Although the mean meperidine dose did not differ (62.5±27.6 vs 51.0±17.3, p=0.18) between the two groups, the mean dose of midazolam in the non-BIS group was lower than in the BIS group (6.8±2.0 vs 5.4±2.1, p=0.01). CONCLUSIONS: BIS monitoring during ESD did not increase the satisfaction of endoscopists or patients and did not lead to an M/M dose reduction. These results demonstrate that BIS monitoring provides no additional benefit to M/M induced sedation during ESD.