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

Study Overview
=================
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.

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

Conditions
-----------------
Biliary Tract Diseases, Pancreatic Diseases

Intervention / Treatment
-----------------
* Procedure: Continuous infusion of propofol
* Procedure: Intermittent bolus injection of propofol
* Drug: Midazolam
* Drug: Propofol


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intermittent bolus injection of propofol<br>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<br>* 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.<br>Drug: Midazolam<br> <br> Drug: Propofol<br> <br> |
| Active Comparator: Continuous infusion of propofol<br>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<br>* 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.<br>Drug: Propofol<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholangiopancreatography, Endoscopic Retrograde