Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
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Brief Summary
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Self-administration of propofol and opioid mixture by the patient him- or herself (patient-controlled sedation, PCS) could be successful alternative to the anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography (ERCP). However, it is not known which opioid would be the most suitable for PCS. The aim of this double-blind study was to compare remifentanil and alfentanil in PCS during ERCP.

Detailed Description
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Deep sedation with propofol has been suggested necessary for successful performance of endoscopic retrograde cholangiopancreatography (ERCP).Airway obstruction, hypoventilation and hypoxemia occurs in deeply sedated patients with a high incidence of 12-30%.As a result of frequent hypoxemia events, deep sedation is associated with increased morbidity and mortality.Careful monitoring of vital signs and involving of anesthesia-trained personal are recommended for deeply sedated patients.Self-administration of propofol by the patient him- or herself (patient-controlled sedation, PCS)could be a safer way to use propofol without the presence of an anesthesiologist. In comparison to the anesthesiologists managed deep sedation the main advantages of PCS are reduced consumption of anesthetics and faster recovery.A combination of propofol and different opioids is widely used for PCS however, it is not known which opioid would be the most suitable one. Remifentanil is a potent opioid with ultra short duration of action and usually administered as a constant infusion. The elimination half-life of alfentanil is 8-32 minutes being about 3 times longer, than that of remifentanil. Both opioids have been evaluated previously in PCS but comparative studies are lacking. This study was carried out in order to compare remifentanil and alfentanil in PCS during ERCP in terms of propofol consumption, sedation levels, endoscopist´s and patient's satisfaction. The investigators also sought information about frequency of sedation related complications associated with the different opioids.

Official Title
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Alfentanil vs Remifentanil in Patient-controlled Sedation During ERCP.A Randomized Double-blind Study

Conditions
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Biliary Tract Diseases, Pancreatic Diseases

Intervention / Treatment
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* Drug: alfentanil
* Drug: remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective ERCP patients Exclusion Criteria: allergy to propofol or opioid analgesics, drug addiction, inability to co-operate, ASA class greater than 3, or patient's refusal.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: remifentanil<br>sedative mixture for PCS consisting of propofol 10mg/ml 20 ml and remifentanil 50 mkg/ml 5 ml | Drug: remifentanil<br>* Remifentanil is a potent ultra short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. Remifentanil is used for sedation as well as combined with other medications for use in general anesthesia. The use of remifentanil has made possible the use of high dose opioid and low dose hypnotic anesthesia, due to synergism between remifentanil and various hypnotic drugs and volatile anesthetics.It is administered in the form remifentanil hydrochloride and in adults is given as an intravenous infusion in doses ranging from 0.1 microgram per kilogram per minute to 0.5 (µg/kg)/min.<br>* Other names: Ultiva;|
| Active Comparator: alfentanil 0.04 mg/ml<br>sedative mixture for PCS consisting of propofol10 mg/ml 20 ml,alfentanil 0.5 mg/ml 2 ml, NaCL 9 mg/ml 3 ml | Drug: alfentanil<br>* Alfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage.<br>* Other names: Alfenta;|
| Active Comparator: alfentanil 0.08 mg/ml<br>sedative mixture for PCS consisting of propofol 10 mg/ml 20 ml, alfentanil 0.5 mg/ml 4 ml,NaCl 9mg/ml 1ml | Drug: alfentanil<br>* Alfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage.<br>* Other names: Alfenta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of propofol and opioid |  | one day | 
| vital signs | Heart rate (HR), electrocardiogram (ECG), breathing rate, peripheral oxygen saturation (SpO2), end tidal carbon dioxide (EtCO2) constant monitoring. Noninvasive blood pressure (NIBP)measuring at 5 min intervals. | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation levels | Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score | one day | 
| pain intensity | Numeric range scale | one day | 
| patient´s and endoscopist´s satisfaction with sedation |  | one day | 
| incidence of nausea |  | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient-controlled sedation, propofol, alfentanil, remifentanil, endoscopic retrograde cholangiopancreatography