Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
Phase 3
19 Years
80 Years
19 Years
80 Years
Open (Enrolling)
Both
Gastric Adenoma, Gastric Cancer
Both
Gastric Adenoma, Gastric Cancer
Trial Information
Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD
Outcome Time Frame:
within the one day after ESD
Safety Issue:
No
Authority:
South Korea: Institutional Review Board
Study ID:
2009-08-037
NCT ID:
NCT01157598
Start Date:
September 2009
Completion Date:
Related Keywords:
- Gastric Adenoma
- Gastric Cancer
- gastric adenoma
- early gastric cancer
- Adenoma
- Stomach Neoplasms
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