Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Hanyang University
Sponsor:
Information provided by (Responsible Party):
Kyo-Sang Yoo, Hanyang University
ClinicalTrials.gov Identifier:
NCT01900938
First received: May 29, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.


Condition Intervention
Biliary Tract Diseases
Pancreatic Diseases
Procedure: Continuous infusion of propofol
Procedure: Intermittent bolus injection of propofol
Drug: Midazolam
Drug: Propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Hanyang University:

Primary Outcome Measures:
  • Satisfaction scores by endoscopist [ Time Frame: 30 minutes after the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events for sedation [ Time Frame: 1 day after the procedure ] [ Designated as safety issue: Yes ]
  • Difficulty scores of maintaining the sedation [ Time Frame: 30 minutes after the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: September 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intermittent bolus injection of propofol
A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
Procedure: Intermittent bolus injection of propofol
A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
Drug: Midazolam Drug: Propofol
Active Comparator: Continuous infusion of propofol
Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
Procedure: Continuous infusion of propofol
Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
Drug: Propofol

Detailed Description:

The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the doses were determined by sedation assistants monitoring the patients. In the intermittent group, a loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol was initially injected and repeated bolus injection of 20 mg of propofol was followed according to patients' sedation level. Sedation related parameters (total dose of propofol, induction/recovery time, patients' cooperation) and adverse events during the procedure were evaluated. Satisfaction scores by endoscopist, assistant, and patients and difficulty scores of maintaining the sedation by assistants were also graded after the procedure.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergone ERCP for biliary and pancreatic diseases

Exclusion Criteria:

  • Comorbid conditions of ASA class 4-5
  • Age under 18 years or over 90 years
  • Pregnancy
  • Past medication history of benzodiazepine or narcotics
  • Known allergy to midazolam or propofol
  • hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900938

Contacts
Contact: Kyo-Sang Yoo, MD, PhD 82-31-560-2178 kyoo@hanyang.ac.kr

Locations
Korea, Republic of
Hanyang University Guri Hospital Not yet recruiting
Guri, Gyeonggi, Korea, Republic of, 471-701
Principal Investigator: Kyo-Sang Yoo, MD, PhD         
Sponsors and Collaborators
Hanyang University
Investigators
Principal Investigator: Kyo-Sang Yoo Hanyang University
  More Information

No publications provided

Responsible Party: Kyo-Sang Yoo, Professor, Hanyang University
ClinicalTrials.gov Identifier: NCT01900938     History of Changes
Other Study ID Numbers: 2012-055
Study First Received: May 29, 2013
Last Updated: July 16, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Hanyang University:
Cholangiopancreatography
Endoscopic Retrograde

Additional relevant MeSH terms:
Pancreatic Diseases
Biliary Tract Diseases
Digestive System Diseases
Propofol
Midazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014