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

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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Intervention / Treatment: Device: infusion pump; Drug: propofol; Drug: fentanyl; Device: infusion pump for patient-controlled sedation; Drug: sedative mixture; Drug: remifentanil hydrochlorid

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol infusion; Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml	Device: infusion pump; anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level; Other Names: -Braun AG; -an infusion pump; Drug: propofol; Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.; Other Names: -Diprivan; -Recofol; -Fresofol; Drug: fentanyl; Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.; Other Names: -fentanyl citrate; -fentanyl
Active Comparator: Patient-controlled sedation; self-administration of propofol and remifentanil mixture during ERCP	Drug: propofol; Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.; Other Names: -Diprivan; -Recofol; -Fresofol; Device: infusion pump for patient-controlled sedation; self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.; Other Names: -Arcomed,Syramed AG,Switzerland; -infusion pump designed for self administration of the drugs; Drug: sedative mixture; Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml); Other Names: -Diprivan; -Ultiva; Drug: remifentanil hydrochlorid; Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details); Other Names: -Ultiva

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation level	sedation level assested with Ramsay,Gillham,OAA/S sedation scores	one day

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Maxim Mazanikov, MD, Helsinki University Central Hospital,Department of Anaesthesiology; Principal Investigator: Marianne Udd, MD, PhD, Helsinki University Central Hospital,Department of Surgery; Principal Investigator: Pekka Aho, MD, PhD, Helsinki University Central Hospital,Department of Vascular Surgery; Principal Investigator: Martti Färkilä, Professor, Helsinki University Central Hospital,Department of Gasroenterology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 3, 2010

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: ERCP; propofol; remifentanil; patient-controlled sedation; sedation level
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Fentanyl; Propofol; Hypnotics and Sedatives
• Other Study ID Numbers: a001c; 2008-007968-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Due to Finnish legal restriction patient data can not be accessed by others but the researches