Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
Gastric Adenoma - Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric adenoma, early gastric cancer
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Name: bispectral index monitoring
Type: Device
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 19 Years
Gender: Both
Criteria: 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.
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: JaeJ Kim, professor - +82-2-3410-3409 - jjkim@skku.edu
Start Date
September 2009
Samsung Medical Center
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page