Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Summary

Self-administration of propofol and opioid mixture by the patient him- or herself (patient-controlled sedation, PCS) could be successful alternative to the anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography (ERCP). However, it is not known which opioid would be the most suitable for PCS. The aim of this double-blind study was to compare remifentanil and alfentanil in PCS during ERCP.

Conditions

• Biliary Tract Diseases
• Pancreatic Diseases

Interventions

DRUG

alfentanil

Alfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage.

DRUG

remifentanil

Remifentanil is a potent ultra short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. Remifentanil is used for sedation as well as combined with other medications for use in general anesthesia. The use of remifentanil has made possible the use of high dose opioid and low dose hypnotic anesthesia, due to synergism between remifentanil and various hypnotic drugs and volatile anesthetics.It is administered in the form remifentanil hydrochloride and in adults is given as an intravenous infusion in doses ranging from 0.1 microgram per kilogram per minute to 0.5 (µg/kg)/min.

Sponsors & Collaborators

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

• Reino Pöyhiä, MD,PhD · Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care

• Maxim Mazanikov, MD · Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care

• Martti Färkkilä, MD,Professor · Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology

• Leena Kylänpää, MD,PhD · Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

• Jorma Halttunen, MD,PhD · Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

• Outi Lindström, MD,PhD · Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

• Harri Mustonen, DSc · Helsinki University Central Hospital, Department of Surgery

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2009-09-30

Completion

2009-09-30

Countries

• Finland

Study Locations