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

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Yonsei University

Status

Terminated

Conditions

Chronic Alcoholism

Treatments

Drug: Midazolam
Drug: Midazolam plus propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT01617707
4-2012-0181

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

11 participants in 2 patient groups

conventional sedation group
Active Comparator group
Description:
midazolam
Treatment:
Drug: Midazolam
BPS group
Experimental group
Description:
midazolam plus propofol
Treatment:
Drug: Midazolam plus propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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