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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01157598
• Other study ID #: 2009-08-037
• Status: Recruiting
• Phase: Phase 3
• First received: July 5, 2010
• Last updated: July 6, 2010
• Start date: September 2009

Study information

• Verified date: July 2010
• Source: Samsung Medical Center
• Contact: Jae.J Kim, professor
• Phone: +82-2-3410-3409
• Email: jjkim[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Adenoma
• Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• bispectral index monitoring
parameter monitoring of bispectral index

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD		within the one day after ESD	No
Secondary	the dose of midazolam and meperidine during ESD with BIS monitoring		within one hour after ESD	No