Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery. (REMISYD)

September 11, 2013 updated by: Pasi Lahtinen, Kuopio University Hospital
Prospective double blind study comparing two remifentanil dosing protocols (0.1 and 0.3 mcg/kg/min) during cardiac surgery. Main outcome measures are postoperative opioid requirements (PCA oxycodone) and postoperative pain (VAS, verbal rating scale).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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
      • Kuopio, Finland, 70210
        • Kuopio University Hospital

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Coronary artery bypass grafting patients

Exclusion Criteria:

  • Psychiatric disorders, sleep apnea, cardiac insufficiency

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
remifentanil o.1 mcg/kg/min
Drug: remifentanil
remifentanil infusion
Active Comparator: 2
remifentanil 0.3 mcg/kg/min
Drug: remifentanil
remifentanil infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative opioid (oxycodone) consumption
Time Frame: Postoperatively 48 hours
Postoperatively 48 hours

Collaborators and Investigators

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

Sponsor

Kuopio University Hospital

Investigators

  • Study Director: Pasi Lahtinen, MD, Department of Anesthesiology and Intensive Care, Kuopio University hospital, Kuopio, 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

September 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 22, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

September 12, 2013

Last Update Submitted That Met QC Criteria

September 11, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5070206
  • EudraCT 2008-000597-21

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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