Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: Study Comparing Midazolam and Propofol With Midazolam
Primary Purpose
Chronic Alcoholism
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Midazolam plus propofol
Midazolam
Sponsored by
About this trial
This is an interventional other trial for Chronic Alcoholism focused on measuring sedation, endoscopy, midazolam, propofol, chronic alcoholics
Eligibility 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
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional sedation group
BPS group
Arm Description
midazolam
midazolam plus propofol
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
completion rate of endoscopy
number of participants with complications
hypoxemia (SpO2<90%), hypotension (SBP<90mmHg), bradycardia (HR<50/min)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01617707
Brief Title
Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: Study Comparing Midazolam and Propofol With Midazolam
Official Title
Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: a Prospective, Randomized Study Comparing Midazolam and Propofol With Midazolam
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
because of difficulties for participants enrollment
Study Start Date
May 9, 2012 (Actual)
Primary Completion Date
January 30, 2015 (Actual)
Study Completion Date
January 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Alcoholism
Keywords
sedation, endoscopy, midazolam, propofol, chronic alcoholics
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional sedation group
Arm Type
Active Comparator
Arm Description
midazolam
Arm Title
BPS group
Arm Type
Experimental
Arm Description
midazolam plus propofol
Intervention Type
Drug
Intervention Name(s)
Midazolam plus propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
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.
Primary Outcome Measure Information:
Title
Satisfaction of endoscopists, nurses and patients
Description
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
Time Frame
about 5 minutes after the end of the procedure
Secondary Outcome Measure Information:
Title
completion rate of endoscopy
Time Frame
about 5 minutes after the end of procedure
Title
number of participants with complications
Description
hypoxemia (SpO2<90%), hypotension (SBP<90mmHg), bradycardia (HR<50/min)
Time Frame
participants will be followed during the procedure and recovery time, an expected average of 20 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: Study Comparing Midazolam and Propofol With Midazolam
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