Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery
Primary Purpose
Coronary Artery Disease, Coronary Artery Bypass Surgery
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
spinal analgesia and anesthesia for coronary artery surgery
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery bypass surgery, anesthesia, general, anesthesia, spinal, heart-lung machine
Eligibility 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
Sites / Locations
- Foothills Medical Centre
Outcomes
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
Full Information
NCT ID
NCT00242697
First Posted
October 19, 2005
Last Updated
October 19, 2005
Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00242697
Brief Title
Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery
Official Title
A Randomized Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Bypass Surgery
Keywords
coronary artery bypass surgery, anesthesia, general, anesthesia, spinal, heart-lung machine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
63 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
spinal analgesia and anesthesia for coronary artery surgery
Primary Outcome Measure Information:
Title
analgesic requirement in the intensive care unit
Title
visual analogue pain scores in the intensive care unit
Title
duration of endotracheal intubation in the intensive care unit
Secondary Outcome Measure Information:
Title
intraoperative hemodynamic variables
Title
intraoperative blood catecholamine and lactate levels
Title
intraoperative anesthetic supplementation
Title
intraoperative vasoactive drug therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles L MacAdams, MD FRCPC
Organizational Affiliation
Department of Anesthesia, Foothills Medical Centre, University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
Citations:
Citation
MacAdams, CL et al. Combined general-spinal vs spinal anesthesia for coronary artery bypass grafting. Can J Anesth 73(Suppl I):A73,2003.
Results Reference
background
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Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery
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