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

December 4, 2020 updated by: Maxim Mazanikov, Helsinki University Central Hospital

Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 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;
  • inability to cooperate;
  • ASA(American Society of Anaesthesiology)class greater than 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: patient-controlled sedation
PCS
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.
Other Names:
  • Arcomed/Syramed AG infusion pump designed for self administration of medicines
ACTIVE_COMPARATOR: target-controlled infusion
TCI
Device: Target-controlled infusion
Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol
Other Names:
  • Arcomed/Syramed AG target-controlled infusion device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sedation degrees
Time Frame: One day
One day
patient's and endoscopist´s satisfaction,
Time Frame: One day
One day
propofol consumption
Time Frame: One day
One day
vital signs:oxygen saturation,blood pressure,heart rate,breathing rate
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Maxim Mazanikov, MD, Helsiki University Central Hospital,Department of Anaesthesiology
  • Principal Investigator: Marianne Udd, MD.,PhD, Helsinki University Central Hospital,Department of Surgery
  • Principal Investigator: Martti Färkilä, Professor, Helsinki University Central Hospital,Department of Gastroenterology
  • Principal Investigator: Harri Mustonen, PhD, Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (ESTIMATE)

February 22, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • a005c
  • 2009-015564-34 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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