Clinical trial NCT01079312: Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endoscopic Retrograde Cholangiopancreatography
Keywords: ERCP
patient-controlled sedation
propofol
remifentanil
sedation level
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: propofol and opioid consumption
timeFrame: one day
measure: vital signs
timeFrame: one day
measure: patient´s and endoscopist´s satisfaction
timeFrame: one day
Secondary outcomes:
measure: sedation level
timeFrame: one day
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital,Department of Anaesthesiology
name: Maxim Mazanikov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Marianne Udd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Outi Lindström, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Leena Kylänpää, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Vascular Surgery
name: Pekka Aho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Jorma Halttunen, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gasroenterology
name: Martti Färkilä, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Anaesthesiology
name: Reino Pöyhiä, Docent
role: STUDY_CHAIR
References:
citation: Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.