Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP
- Conditions
- Biliary Tract DiseasesPancreatic Diseases
- Interventions
- Procedure: Intermittent bolus injection of propofolProcedure: Continuous infusion of propofol
- Registration Number
- NCT01900938
- Lead Sponsor
- Hanyang University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
- Patients undergone ERCP for biliary and pancreatic diseases
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent bolus injection of propofol 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. Continuous infusion of propofol 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. Continuous infusion of propofol 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. Intermittent bolus injection of propofol Midazolam 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. Intermittent bolus injection of propofol 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.
- Primary Outcome Measures
Name Time Method Satisfaction scores by endoscopist 30 minutes after the procedure
- Secondary Outcome Measures
Name Time Method Adverse events for sedation 1 day after the procedure Difficulty scores of maintaining the sedation 30 minutes after the procedure
Trial Locations
- Locations (1)
Hanyang University Guri Hospital
🇰🇷Guri, Gyeonggi, Korea, Republic of