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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01157598
Recruitment Status : Unknown
Verified July 2010 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : July 7, 2010
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Gastric Adenoma Gastric Cancer Device: bispectral index monitoring Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. the dose of midazolam and meperidine during ESD with BIS monitoring [ Time Frame: within one hour after ESD ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Samsung Medical Center IRB, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01157598     History of Changes
Other Study ID Numbers: 2009-08-037
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

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
Midazolam
Meperidine
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics