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

NCT01617707 | Terminated

• 1 other identifier: 4-2012-0181
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Alcoholism

Keywords

sedation; endoscopy; midazolam; propofol; chronic alcoholics

Outcome Measures

Primary Outcomes (1)

• Satisfaction of endoscopists, nurses and patients

  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

  about 5 minutes after the end of the procedure

Secondary Outcomes (2)

• 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

Study Arms (2)

conventional sedation group

ACTIVE COMPARATOR

midazolam

Drug: Midazolam

BPS group

EXPERIMENTAL

midazolam plus propofol

Drug: Midazolam plus propofol

Interventions

Midazolam plus propofol DRUG

In both study arms, patients who were 20-70 years of age received an initial intravenous bolus of 0.05mg/kg of midazolam, while patients ≥71 years of age received an initial intravenous dose of 1mg of midazolam. After 2min following this initial dose of midazolam, the conventional sedation group received additional boluses as needed of 1 to 2 mg of midazolam at the discretion of the endoscopist, to target moderate sedation. The BPS group received an initial 0.5mg/kg bolus of intravenous propofol at 2min after midazolam administration. Subsequent incremental boluses of 10 to 20 mg of propofol were allowed to be given at the discretion of the endoscopist every 30s to target moderate sedation.

BPS group

Midazolam DRUG

In both study arms, patients who were 20-70 years of age received an initial intravenous bolus of 0.05mg/kg of midazolam, while patients ≥71 years of age received an initial intravenous dose of 1mg of midazolam. After 2min following this initial dose of midazolam, the conventional sedation group received additional boluses as needed of 1 to 2 mg of midazolam at the discretion of the endoscopist, to target moderate sedation. The BPS group received an initial 0.5mg/kg bolus of intravenous propofol at 2min after midazolam administration. Subsequent incremental boluses of 10 to 20 mg of propofol were allowed to be given at the discretion of the endoscopist every 30s to target moderate sedation.

conventional sedation group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Midazolam; Propofol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 12, 2012
• Study Start: May 9, 2012
• Primary Completion: January 30, 2015
• Study Completion: January 30, 2015
• Last Updated: November 28, 2017

Record last verified: 2014-03

Locations

KR (1)