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

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer; Gastric Adenoma

Treatments: Device: bispectral index monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01157598

2009-08-037

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

BIS group

Active Comparator group

Treatment:

Device: bispectral index monitoring

non BIS group

Placebo Comparator group

Treatment:

Device: bispectral index monitoring