Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
Phase 3
- Conditions
- Gastric AdenomaGastric Cancer
- Interventions
- Device: bispectral index monitoring
- Registration Number
- NCT01157598
- Lead Sponsor
- Samsung Medical Center
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- gastric adenomas, differentiated-type gastric cancers greater than 30 mm in diameter without ulceration and gastric cancers up to 30 mm with ulceration, or minute submucosal invasion
Exclusion Criteria
- if they were under 18 years of age
- had an ASA classification of 4-5
- were pregnant
- had a history of stroke or an allergy to sedative drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIS group bispectral index monitoring - non BIS group bispectral index monitoring -
- Primary Outcome Measures
Name Time Method the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD within the one day after ESD
- Secondary Outcome Measures
Name Time Method the dose of midazolam and meperidine during ESD with BIS monitoring within one hour after ESD
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of