Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: Study Comparing Midazolam and Propofol With Midazolam

Not Applicable

Terminated

• Conditions: Chronic Alcoholism
• Interventions: Drug: Midazolam plus propofol; Drug: Midazolam

• Registration Number: NCT01617707
• Lead Sponsor: Yonsei University

Brief Summary

Sedative endoscopic examination using sedative premedication has been undertaken to induce conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely used as a sedative premedication because it has lots of advantages, such as a short half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However, midazolam has been used regardless of whether or not alcohol although using midazolam in chronic alcoholics is related to paradoxical reaction, characterized by increased talkativeness, emotional release, excitement, and excessive movement. In recent years, propofol has been used safety and effectively in sedative GI endoscopy because of its potent hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam) with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic GI endoscopic procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-09
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Status Verified: 2014-03
• Primary Completion: 2015-01-30
• Study Completion: 2015-01-30
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• age ≥ 20
• ECOG ≥ 2
• patient who consents to enroll the trial

Exclusion Criteria

• age < 20
• pregnant or lactating women
• American Society of Anesthesiology (ASA) physical status class V
• chronic pulmonary disease
• history of allergic to propofol
• history of complication of sedation endoscope
• liver failure or hepatic encephalopathy
• who didn't consented to enroll the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPS group	Midazolam plus propofol	midazolam plus propofol
conventional sedation group	Midazolam	midazolam

Primary Outcome Measures

Name	Time	Method
Satisfaction of endoscopists, nurses and patients	about 5 minutes after the end of the procedure	endoscopists and nurses - about 5 minutes after the end of the procedure / patients - upon meeting discharge criteria (modified Aldrete score), an expected average of 20min

Secondary Outcome Measures

Name	Time	Method
completion rate of endoscopy	about 5 minutes after the end of procedure
number of participants with complications	participants will be followed during the procedure and recovery time, an expected average of 20 min	hypoxemia (SpO2\<90%), hypotension (SBP\<90mmHg), bradycardia (HR\<50/min)

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of