Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Summary

Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).

Conditions

• Sedation

Interventions

DEVICE

Patient-controlled sedation

Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.

DEVICE

Target-controlled infusion

Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol

Sponsors & Collaborators

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

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

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

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

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

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

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

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

• Harri Mustonen, PhD · Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2010-11-30

Completion

2010-11-30

Countries

• Finland

Study Locations