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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01617707
First received: June 1, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Chronic Alcoholism
Drug: Midazolam plus propofol
Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: a Prospective, Randomized Study Comparing Midazolam and Propofol With Midazolam

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Satisfaction of endoscopists, nurses and patients [ Time Frame: about 5 minutes after the end of the procedure ] [ Designated as safety issue: No ]
    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:
  • completion rate of endoscopy [ Time Frame: about 5 minutes after the end of procedure ] [ Designated as safety issue: No ]
  • number of participants with complications [ Time Frame: participants will be followed during the procedure and recovery time, an expected average of 20 min ] [ Designated as safety issue: No ]
    hypoxemia (SpO2<90%), hypotension (SBP<90mmHg), bradycardia (HR<50/min)


Estimated Enrollment: 56
Study Start Date: June 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional sedation group
midazolam
Drug: Midazolam
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.
Experimental: BPS group
midazolam plus propofol
Drug: Midazolam plus propofol
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617707

Contacts
Contact: Soo Jung Park, MD 82-10-6440-7321 sjpark@yuhs.ac

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Soo Jung Park, MD    82-10-6440-7321    sjpark@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01617707     History of Changes
Other Study ID Numbers: 4-2012-0181
Study First Received: June 1, 2012
Last Updated: March 4, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
sedation
endoscopy
midazolam
propofol
chronic alcoholics

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Midazolam
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014