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Trial Title:
Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
NCT ID:
NCT01157598
Condition:
Gastric Adenoma
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Adenoma
Conditions: Keywords:
gastric adenoma
early gastric cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Device
Intervention name:
bispectral index monitoring
Description:
parameter monitoring of bispectral index
Arm group label:
BIS group
Arm group label:
non BIS group
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
19 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
135-710
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
JaeJ Kim, professor
Phone:
+82-2-3410-3409
Email:
jjkim@skku.edu
Investigator:
Last name:
JaeJ Kim, professor
Email:
Principal Investigator
Start date:
September 2009
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01157598
