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

Phase 4

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Interventions: Device: infusion pump; Device: infusion pump for patient-controlled sedation; Drug: propofol; Drug: fentanyl; Drug: sedative mixture; Drug: remifentanil hydrochlorid

• Registration Number: NCT01079312
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol infusion	infusion pump	Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml
Patient-controlled sedation	infusion pump for patient-controlled sedation	self-administration of propofol and remifentanil mixture during ERCP
Patient-controlled sedation	propofol	self-administration of propofol and remifentanil mixture during ERCP
Propofol infusion	fentanyl	Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml
Patient-controlled sedation	remifentanil hydrochlorid	self-administration of propofol and remifentanil mixture during ERCP
Patient-controlled sedation	sedative mixture	self-administration of propofol and remifentanil mixture during ERCP
Propofol infusion	propofol	Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
sedation level	one day	sedation level assested with Ramsay,Gillham,OAA/S sedation scores

Trial Locations

Locations (1)

Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit; 🇫🇮 Helsinki, Uusimaa, Finland