Chronic Alcoholism
Conditions
Keywords
sedation, endoscopy, midazolam, propofol, chronic alcoholics
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.
Interventions
DRUGMidazolam 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.
DRUGMidazolam
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
South Korea
Outcome results
None listed