Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery. - Full Text View

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

First Received on September 22, 2008. Last Updated on June 28, 2011 History of Changes

Sponsor:	Kuopio University Hospital
Information provided by:	Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00757198

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 IV

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

Drug Information available for: Remifentanil hydrochloride Remifentanil

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 February 09, 2012