Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery
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Purpose
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 |
|---|---|---|
|
Coronary Artery Disease Coronary Artery Bypass Surgery |
Procedure: spinal analgesia and anesthesia for coronary artery surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery |
- analgesic requirement in the intensive care unit
- visual analogue pain scores in the intensive care unit
- duration of endotracheal intubation in the intensive care unit
- intraoperative hemodynamic variables
- intraoperative blood catecholamine and lactate levels
- intraoperative anesthetic supplementation
- intraoperative vasoactive drug therapy
| 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.
Eligibility| Ages Eligible for Study: | 25 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients undergoing non-emergent primary coronary artery bypass grafting using cardiopulmonary bypass
Exclusion Criteria:
- < 25 or > 80 years of age
- left ventricular ejection fraction < 35%
- receiving inotropic or intraaortic balloon therapy at time of surgery
- receiving intravenous heparin therapy at time of surgery
- pre-existing back problems in the lumbar area
- clinical or laboratory evidence of coagulopathy
Contacts and Locations| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00242697 History of Changes |
| Other Study ID Numbers: | CARF1 |
| Study First Received: | October 19, 2005 |
| Last Updated: | October 19, 2005 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Calgary:
|
coronary artery bypass surgery anesthesia, general anesthesia, spinal heart-lung machine |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013