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

Condition(s) targeted: Endoscopic Retrograde Cholangiopancreatography

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

Phase: Phase 4

Status: Completed

Sponsored by: Helsinki University Central Hospital

Official(s) and/or principal investigator(s):
Maxim Mazanikov, MD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Anaesthesiology
Marianne Udd, MD, PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Surgery
Outi Lindström, MD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Surgery
Leena Kylänpää, Docent, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Surgery
Pekka Aho, MD, PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Vascular Surgery
Jorma Halttunen, Docent, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Surgery
Martti Färkilä, Professor, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Gasroenterology
Reino Pöyhiä, Docent, Study Chair, Affiliation: Helsinki University Central Hospital,Department of Anaesthesiology

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

propofol and opioid consumption

vital signs

patient´s and endoscopist´s satisfaction

Secondary outcome: sedation level

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit, Helsinki, Uusimaa 00029, Finland

Starting date: January 2009
Last updated: July 4, 2012