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

Samsung Medical Center56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Gastric Adenoma Gastric Cancer

Interventions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

the dose of midazolam and meperidine during ESD with BIS monitoring

Time frame: within one hour after ESD

Central Contacts

Jae.J Kim, professor

CONTACT

+82-2-3410-3409 jjkim@skku.edu

Ki Joo Kang, Dr