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

Chronic Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01617707
• Other study ID #: 4-2012-0181
• Status: Terminated
• Phase: N/A
• First received: June 1, 2012
• Last updated: November 26, 2017
• Start date: May 9, 2012
• Est. completion date: January 30, 2015

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 30, 2015
• Est. primary completion date: January 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Chronic Alcoholism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	completion rate of endoscopy		about 5 minutes after the end of procedure
Secondary	number of participants with complications	hypoxemia (SpO2<90%), hypotension (SBP<90mmHg), bradycardia (HR<50/min)	participants will be followed during the procedure and recovery time, an expected average of 20 min