Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01157598
First received: July 5, 2010
Last updated: July 6, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Gastric Adenoma
Gastric Cancer
Device: bispectral index monitoring
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD [ Time Frame: within the one day after ESD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the dose of midazolam and meperidine during ESD with BIS monitoring [ Time Frame: within one hour after ESD ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: September 2009
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BIS group Device: bispectral index monitoring
parameter monitoring of bispectral index
Placebo Comparator: non BIS group Device: bispectral index monitoring
parameter monitoring of bispectral index

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157598

Contacts
Contact: Jae.J Kim, professor +82-2-3410-3409 jjkim@skku.edu
Contact: Ki Joo Kang, Dr +82-2-3410-3409 kj74.kang@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: JaeJ Kim, professor    +82-2-3410-3409    jjkim@skku.edu   
Principal Investigator: JaeJ Kim, professor         
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center IRB, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01157598     History of Changes
Other Study ID Numbers: 2009-08-037
Study First Received: July 5, 2010
Last Updated: July 6, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
gastric adenoma
early gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Adenoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 30, 2014