Clinical trial NCT00242697: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Coronary Artery Bypass Surgery
Keywords: coronary artery bypass surgery
anesthesia, general
anesthesia, spinal
heart-lung machine
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-10-20
Enrollment: 63
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: analgesic requirement in the intensive care unit
measure: visual analogue pain scores in the intensive care unit
measure: duration of endotracheal intubation in the intensive care unit
Secondary outcomes:
measure: intraoperative hemodynamic variables
measure: intraoperative blood catecholamine and lactate levels
measure: intraoperative anesthetic supplementation
measure: intraoperative vasoactive drug therapy
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: Department of Anesthesia, Foothills Medical Centre, University of Calgary
name: Charles L MacAdams, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacAdams, CL et al. Combined general-spinal vs spinal anesthesia for coronary artery bypass grafting. Can J Anesth 73(Suppl I):A73,2003.