Biliary Tract Diseases, Pancreatic Diseases
Conditions
Keywords
Cholangiopancreatography, Endoscopic Retrograde
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.
Interventions
PROCEDUREContinuous 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.
PROCEDUREIntermittent 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.
DRUGMidazolam
DRUGPropofol
Sponsors
Hanyang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Satisfaction scores by endoscopist | 30 minutes after the procedure |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events for sedation | 1 day after the procedure |
| Difficulty scores of maintaining the sedation | 30 minutes after the procedure |
Countries
South Korea
Contacts
Primary ContactKyo-Sang Yoo, MD, PhD
Outcome results
None listed