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

Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Biliary Tract Diseases; Pancreatic Diseases
• Intervention / Treatment: Drug: Midazolam; Drug: Propofol; Procedure: Intermittent bolus injection of propofol; Procedure: Continuous infusion of 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.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Guri, Gyeonggi, Korea, Republic of, 471-701
      • Hanyang University Guri Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Midazolam; Drug: Propofol; 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.
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.	Drug: Propofol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Satisfaction scores by endoscopist	30 minutes after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events for sedation	1 day after the procedure
Difficulty scores of maintaining the sedation	30 minutes after the procedure

Collaborators and Investigators

• Sponsor: Hanyang University
• Investigators: Principal Investigator: Kyo-Sang Yoo, Hanyang University

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): July 17, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Cholangiopancreatography; Endoscopic Retrograde
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Biliary Tract Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Propofol
• Other Study ID Numbers: 2012-055