Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 5, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedJuly 7, 2010
July 1, 2010
1 year
July 5, 2010
July 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD
within the one day after ESD
Secondary Outcomes (1)
the dose of midazolam and meperidine during ESD with BIS monitoring
within one hour after ESD
Study Arms (2)
BIS group
ACTIVE COMPARATORnon BIS group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 5, 2010
First Posted
July 7, 2010
Study Start
September 1, 2009
Primary Completion
September 1, 2010
Last Updated
July 7, 2010
Record last verified: 2010-07