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Sponsored by: |
Kuopio University Hospital |
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Information provided by: | Kuopio University Hospital |
ClinicalTrials.gov Identifier: | NCT00757198 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery. |
Estimated Enrollment: | 90 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
remifentanil o.1 mcg/kg/min
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Drug: remifentanil
remifentanil infusion
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2: Active Comparator
remifentanil 0.3 mcg/kg/min
|
Drug: remifentanil
remifentanil infusion
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pasi Lahtinen, MD | +358-40-7368286 | pasi.lahtinen@kuh.fi |
Contact: Pawel Florkiewicz, MD | +358-40-3539440 | pawel.florkiewicz@kuh.fi |
Finland | |
Kuopio University hospital | Recruiting |
Kuopio, Finland, 70210 | |
Contact: Pasi Lahtinen pasi.lahtinen@kuh.fi | |
Sub-Investigator: Tadeusz Musialowicz, MD |
Study Director: | Pasi Lahtinen, MD | Department of Anesthesiology and Intensive Care, Kuopio University hospital, Kuopio, Finland |
Responsible Party: | Kuopio university hospital/Department of Anesthesiology and intensive care ( Pasi Lahtinen ) |
Study ID Numbers: | KUH5070206, EudraCT 2008-000597-21 |
Study First Received: | September 22, 2008 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00757198 History of Changes |
Health Authority: | Finland: National Agency for Medicines |
pain, postoperative, opioid, PCA, cardiac surgery |
Anesthetics, Intravenous Remifentanil Anesthetics, General Hypnotics and Sedatives Anesthetics Central Nervous System Depressants |
Pain Peripheral Nervous System Agents Analgesics Analgesics, Opioid Pain, Postoperative |
Anesthetics, Intravenous Remifentanil Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions Sensory System Agents |
Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |