Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography

Study Overview
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Brief Summary
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Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography (ERCP). Combination of sedatives and opioids is associated with increased morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system (patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative studies with PCS for ERCP are few. Therefore, the main objective of this randomized controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists during ERCP.

Official Title
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Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography

Conditions
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Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
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* Drug: Propofol sedation by nurse anaesthestist
* Drug: Patient-controlled propofol sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need for ERCP Able to speak and read swedish Exclusion Criteria: Allergy to propofol Severe cardiopulmonary disease (ASA IV) Confusion or dementia

Ages Eligible for Study
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Minimum Age: 18 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 sedation by nurse anaesthetist<br>Nurse anaesthetists managed infusion of propofol 10 mg/ml at doses of 0.2 - 0.8 ml/kg during ERCP. The target of moderate sedation was achieved within 5 minutes from start of the sedation. | Drug: Propofol sedation by nurse anaesthestist<br>* Propofol (10 mg/ml) is a short-acting, intravenously administered hypnotic agent used for light-moderate-deep sedation. Patient-controlled sedation: self-administration of propofol boluses of 5 mg with zero lock-out time. Administration time for the pump was 12 sec, equivalent to maximum delivery of 25 mg of propofol per minute. Propofol sedation by nurse anaesthetists:<br>|
| Active Comparator: Patient-controlled propofol sedation<br>Self-administration of propofol via patient-controlled sedation pump (CME...). No programmed lock-out period, no dose limit or background infusion. 5 mg propofol/effectuated demand from the patients. Capacity of the pump was 6 possible doses per minute. Before start of ERCP the patients were allowed to sedate themselves to a sense of heavy tiredness. | Drug: Patient-controlled propofol sedation<br>* Propofol (10 mg/ml) is a short-acting, intravenously administered hypnotic agent used for light-moderate-deep sedation. Self-administration of propofol via patient-controlled sedation pump (CME T-34L PCA). No programmed lock-out period, no dose limit or background infusion. 5 mg propofol/effectuated demand from the patients. Capacity of the pump was 6 possible doses per minute. Before start of ERCP the patients were allowed to sedate themselves to a sense of heavy tiredness.<br>|
| No Intervention: Midazolam sedation by the ERCP-team<br>Midazolam doses for sedation during ERCP. Initial dose of 2-3 mg and after ERCP start, 1-2 mg as additional doses. Maximum total dose 6-8 mg. ERCP performing doctor is responsible for dose ordination. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatability | Registration of number of failures (where procedure is interrupted as a result of inadequate sedation). Comparison data between propofol PCS and nurse anaesthetists sedation using propofol and control group (midazolam). | one day (per-procedural) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs | Vital signs and interventions of nurse anaesthetists. Data on heart rate, blood pressure, peripheral oxygen saturatuion, respiratory rate, delivery of oxygen, airway obstruction assessment, airway manipulation. | one and a half year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, propofol, patient-controlled, safety