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

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

Interventions

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

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.

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.

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.

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)

DRUG

remifentanil hydrochlorid

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

Sponsors & Collaborators

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

• Maxim Mazanikov, MD · Helsinki University Central Hospital,Department of Anaesthesiology

• Marianne Udd, MD, PhD · Helsinki University Central Hospital,Department of Surgery

• Outi Lindström, MD · Helsinki University Central Hospital,Department of Surgery

• Leena Kylänpää, Docent · Helsinki University Central Hospital,Department of Surgery

• Pekka Aho, MD, PhD · Helsinki University Central Hospital,Department of Vascular Surgery

• Jorma Halttunen, Docent · Helsinki University Central Hospital,Department of Surgery

• Martti Färkilä, Professor · Helsinki University Central Hospital,Department of Gasroenterology

• Reino Pöyhiä, Docent · Helsinki University Central Hospital,Department of Anaesthesiology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2009-04-30

Completion

2009-04-30

Countries

• Finland

Study Locations