Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
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Brief Summary
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Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.

Detailed Description
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80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary.

Official Title
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Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study

Conditions
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Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
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* Device: infusion pump
* Device: infusion pump for patient-controlled sedation
* Drug: propofol
* Drug: fentanyl
* Drug: sedative mixture
* Drug: remifentanil hydrochlorid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective ERCP-patients Exclusion Criteria: allergy to propofol or opioid; ASA-class (American Society of Anaesthesiology) greater than 3; inability to co-operate; drugs abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol infusion<br>Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml | Device: infusion pump<br>* anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level<br>* Other names: -an infusion pump;Drug: propofol<br>* Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.<br>* Other names: -Fresofol;Drug: fentanyl<br>* Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.<br>* Other names: -fentanyl;|
| Active Comparator: Patient-controlled sedation<br>self-administration of propofol and remifentanil mixture during ERCP | Device: infusion pump for patient-controlled sedation<br>* self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.<br>* Other names: -infusion pump designed for self administration of the drugs;Drug: propofol<br>* Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.<br>* Other names: -Fresofol;Drug: sedative mixture<br>* Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)<br>* Other names: -Diprivan;Drug: remifentanil hydrochlorid<br>* Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)<br>* Other names: -Ultiva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol and opioid consumption | total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure | one day | 
| vital signs | heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration | one day | 
| patient´s and endoscopist´s satisfaction | Likert scale 1-7 | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation level | sedation level assested with Ramsay,Gillham,OAA/S sedation scores | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, patient-controlled sedation, propofol, remifentanil, sedation level