NCT01157598

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Adenoma
• Gastric Cancer

Interventions

Type	Name	Description
DEVICE	bispectral index monitoring	parameter monitoring of bispectral index

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-09-01
• First posted: 2010-07-07
• Last updated: 2010-07-07

Locations

1 site across 1 country: South Korea