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

NCT01079312 | Completed Phase 4

• 2 other identifiers: a001c2008-007968-42
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Retrograde Cholangiopancreatography

Keywords

ERCP; patient-controlled sedation; propofol; remifentanil; sedation level

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• sedation level

  one day

Study Arms (2)

Propofol infusion

ACTIVE COMPARATOR

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

Device: infusion pump; Drug: propofol; Drug: fentanyl

Patient-controlled sedation

ACTIVE COMPARATOR

self-administration of propofol and remifentanil mixture during ERCP

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

Interventions

infusion pump DEVICE

anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level

Also known as: -Braun AG, -an infusion pump

Propofol infusion

infusion pump for patient-controlled sedation DEVICE

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.

Also known as: -Arcomed,Syramed AG,Switzerland, -infusion pump designed for self administration of the drugs

Patient-controlled sedation

propofol DRUG

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.

Also known as: -Diprivan, -Recofol, -Fresofol

Patient-controlled sedation; Propofol infusion

fentanyl DRUG

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.

Also known as: -fentanyl citrate, -fentanyl

Propofol infusion

sedative mixture DRUG

Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)

Also known as: -Ultiva, -Diprivan

Patient-controlled sedation

remifentanil hydrochlorid DRUG

Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)

Also known as: -Ultiva

Patient-controlled sedation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective ERCP-patients

You may not qualify if:

• allergy to propofol or opioid;
• ASA-class (American Society of Anaesthesiology) greater than 3;
• inability to co-operate;
• drugs abuse.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (1)

• 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.

  PMID: 21295639 RESULT

MeSH Terms

Interventions

Infusion Pumps; Propofol; Fentanyl; Remifentanil

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Artificial Organs; Surgical Equipment; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids

Study Officials

• 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

• Outi Lindström, MD

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Leena Kylänpää, Docent

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Pekka Aho, MD, PhD

  Helsinki University Central Hospital,Department of Vascular Surgery

  PRINCIPAL INVESTIGATOR

• Jorma Halttunen, Docent

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Martti Färkilä, Professor

  Helsinki University Central Hospital,Department of Gasroenterology

  PRINCIPAL INVESTIGATOR

• Reino Pöyhiä, Docent

  Helsinki University Central Hospital,Department of Anaesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)