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Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery
This study has been completed.
First Received: October 19, 2005   No Changes Posted
Sponsors and Collaborators: University of Calgary
Canadian Institutes of Health Research (CIHR)
Information provided by: University of Calgary
ClinicalTrials.gov Identifier: NCT00242697
  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 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242697

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Charles L MacAdams, MD FRCPC Department of Anesthesia, Foothills Medical Centre, University of Calgary
  More Information

Publications:
MacAdams, CL et al. Combined general-spinal vs spinal anesthesia for coronary artery bypass grafting. Can J Anesth 73(Suppl I):A73,2003.

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

Keywords provided by University of Calgary:
coronary artery bypass surgery
anesthesia, general
anesthesia, spinal
heart-lung machine

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Central Nervous System Depressants
Anesthetics
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009