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

• ClinicalTrials.gov Identifier: NCT01617707
• Recruitment Status: Terminated
• First Posted: June 12, 2012
• Last Update Posted: November 28, 2017
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Tracking Information

• First Submitted Date: June 1, 2012
• First Posted Date: June 12, 2012
• Last Update Posted Date: November 28, 2017
• Actual Study Start Date: May 9, 2012
• Actual Primary Completion Date: January 30, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 11, 2012)

Satisfaction of endoscopists, nurses and patients [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 11, 2012)

• completion rate of endoscopy [ Time Frame: about 5 minutes after the end of procedure ]
• number of participants with complications [ Time Frame: 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Other
• Condition: 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.
• 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.

Study Arms

• Active Comparator: conventional sedation group
  midazolam
  Intervention: Drug: Midazolam
• Experimental: BPS group
  midazolam plus propofol
  Intervention: Drug: Midazolam plus propofol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 26, 2017): 11
• Original Estimated Enrollment (submitted: June 11, 2012): 56
• Actual Study Completion Date: January 30, 2015
• Actual Primary Completion Date: January 30, 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01617707
• Other Study ID Numbers: 4-2012-0181
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yonsei University
• Study Sponsor: Yonsei University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Yonsei University
• Verification Date: March 2014