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Sponsors and Collaborators: |
University of Calgary Canadian Institutes of Health Research (CIHR) |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00242697 |
Use of neuraxial agents in anesthesia for cardiac surgery is expanding. We have used combined general-spinal anesthesia for cardiac surgery for 12 years. We hypothesized that compared to general anesthesia, the combined techniques would provide comparable intraoperative hemodynamics and improved postoperative analgesia. This study subjected these techniques to a double-blind randomized trial.
Condition | Intervention | Phase |
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Coronary Artery Disease Coronary Artery Bypass Surgery |
Procedure: spinal analgesia and anesthesia for coronary artery surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery |
Estimated Enrollment: | 63 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | July 2003 |
Use of neuraxial agents in anesthesia for cardiac surgery is expanding. We have used combined general-spinal anesthesia for cardiac surgery for 12 years. We performed a trial in order to determine if our clinical impressions of the techniques would be confirmed. We hypothesized that compared to general anesthesia, the combined techniques would provide comparable intraoperative hemodynamics and improved postoperative analgesia.
This study subjected these techniques to a double-blind randomized trial.
METHODS
After IRB approval, 63 consenting patients undergoing non-emergent coronary artery bypass grafting (CABG) entered a randomized, double-blind trial. Patients received lorazepam 0.03 mg/kg preoperatively, and midazolam 0.03 mg/kg during line insertion and induction. Spinal procedures, performed by an unblinded study anesthesiologist, preceded general anesthesia, which was induced with propofol and rocuronium, and maintained with isoflurane through CPB, and propofol thereafter. All caregivers were blinded to group assignment. Opioid and spinal management defined 3 groups:
GA: Sufentanil IV: 3 μg/kg induction, 1 μg/kg x 2 prn; mock spinal SO: Sufentanil IV: 0.2 μg/kg induction, 0.1 μg/kg x 2 prn; Spinal: sufentanil 50 μg, morphine 0.5 mg, hyperbaric
SL: Sufentanil IV: 0.2 μg/kg induction, 0.1 μg/kg x 2 prn; Spinal: sufentanil 25 μg, morphine 0.5 mg, bupivacaine 9.75 mg, hyperbaric
When patients were stable in ICU, propofol was stopped and an extubation protocol begun. Patients received scheduled NSAID and prn opioid, IV or PO. The chi-square test and ANOVA using the Scheffe method for multiple comparisons were applied appropriately.
The primary end points of the study were analgesic requirements, visual analogue pain scores, and duration of endotracheal intubation in the intensive care unit. Secondary endpoints were intraoperative hemodynamic variables, blood catecholamine and lactate levels, anesthetic supplementation, and vasoactive drug support.
Ages Eligible for Study: | 25 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
Foothills Medical Centre | |
Calgary, Alberta, Canada, T2N 2T9 |
Principal Investigator: | Charles L MacAdams, MD FRCPC | Department of Anesthesia, Foothills Medical Centre, University of Calgary |
Study ID Numbers: | CARF1 |
Study First Received: | October 19, 2005 |
Last Updated: | October 19, 2005 |
ClinicalTrials.gov Identifier: | NCT00242697 History of Changes |
Health Authority: | Canada: Health Canada |
coronary artery bypass surgery anesthesia, general anesthesia, spinal heart-lung machine |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Central Nervous System Depressants Anesthetics Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Anesthetics Central Nervous System Depressants |
Arteriosclerosis Pharmacologic Actions Coronary Disease Therapeutic Uses Cardiovascular Diseases Central Nervous System Agents Coronary Artery Disease |