Clinical Trial: Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

Brief Summary: Background: Endoscopic submucosal dissection (ESD) usually requires adequate level of sedation due to lengthy and uncomfortable procedure. Propofol induced sedation with bispectral index (BIS) monitoring has been reported to lead to higher satisfaction of patients and endoscopists during ESD. However, there is no data about efficacy of midazolam and meperidine induced sedation with BIS monitoring during ESD. This study was to evaluate whether midazolam and meperidine induced sedation with BIS monitoring could improve the satisfaction and reduce the dose of midazolam and meperidine during ESD.

Detailed Summary:
Sponsor: Samsung Medical Center

Current Primary Outcome: the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD [ Time Frame: within the one day after ESD ]

Original Primary Outcome: Same as current

Current Secondary Outcome: the dose of midazolam and meperidine during ESD with BIS monitoring [ Time Frame: within one hour after ESD ]

Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: July 5, 2010
Date Started: September 2009
Date Completion:
Last Updated: July 6, 2010
Last Verified: July 2010