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

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Endoscopic Retrograde Cholangiopancreatography

Treatments: Drug: sedative mixture; Drug: fentanyl; Drug: propofol; Device: infusion pump for patient-controlled sedation; Device: infusion pump; Drug: remifentanil hydrochlorid

Study type: Interventional

Funder types: Other

Identifiers

NCT01079312

a001c

2008-007968-42 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Propofol infusion

Active Comparator group

Description:

Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml

Treatment:

Device: infusion pump

Drug: propofol

Drug: fentanyl

Patient-controlled sedation

Active Comparator group

Description:

self-administration of propofol and remifentanil mixture during ERCP

Treatment:

Drug: remifentanil hydrochlorid

Drug: propofol

Device: infusion pump for patient-controlled sedation

Drug: sedative mixture