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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00757198
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : September 12, 2013
Sponsor:
Information provided by (Responsible Party):
Pasi Lahtinen, Kuopio University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: remifentanil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery.
Study Start Date : September 2008
Primary Completion Date : November 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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

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



Primary Outcome Measures :
  1. Postoperative opioid (oxycodone) consumption [ Time Frame: Postoperatively 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery bypass grafting patients

Exclusion Criteria:

  • Psychiatric disorders, sleep apnea, cardiac insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757198


Locations
Finland
Kuopio University hospital
Kuopio, Finland, 70210
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Study Director: Pasi Lahtinen, MD Department of Anesthesiology and Intensive Care, Kuopio University hospital, Kuopio, Finland

Responsible Party: Pasi Lahtinen, PhD,MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00757198     History of Changes
Other Study ID Numbers: KUH5070206
EudraCT 2008-000597-21
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

Keywords provided by Pasi Lahtinen, 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
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics