Status:
UNKNOWN
Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
Lead Sponsor:
Samsung Medical Center
Conditions:
Gastric Adenoma
Gastric Cancer
Eligibility:
All Genders
19-80 years
Phase:
PHASE3
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) monitor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01157598
Start Date
September 1 2009
Last Update
July 7 2010
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710