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

This study is currently recruiting participants.
Verified June 2011 by Kuopio University Hospital
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00757198
First received: September 22, 2008
Last updated: June 28, 2011
Last verified: June 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Pain
 Drug: remifentanil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery.

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Postoperative opioid (oxycodone) consumption [ Time Frame: Postoperatively 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery bypass grafting patients

Exclusion Criteria:

  • Psychiatric disorders, sleep apnea, cardiac insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757198

Contacts
Contact: Pasi Lahtinen, MD +358-40-7368286 pasi.lahtinen@kuh.fi
Contact: Pawel Florkiewicz, MD +358-40-3539440 pawel.florkiewicz@kuh.fi

Locations
Finland
Kuopio University hospital Recruiting
Kuopio, Finland, 70210
Contact: Pasi Lahtinen         pasi.lahtinen@kuh.fi    
Sub-Investigator: Tadeusz Musialowicz, MD            
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Study Director: Pasi Lahtinen, MD Department of Anesthesiology and Intensive Care, Kuopio University hospital, Kuopio, Finland
  More Information

No publications provided

Responsible Party: Pasi Lahtinen, Kuopio university hospital/Department of Anesthesiology and intensive care
ClinicalTrials.gov Identifier: NCT00757198     History of Changes
Other Study ID Numbers: KUH5070206, EudraCT 2008-000597-21
Study First Received: September 22, 2008
Last Updated: June 28, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
pain, postoperative, opioid, PCA, cardiac surgery

Additional relevant MeSH terms:
Analgesics
Remifentanil
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 21, 2013