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Completed

NCT Number: NCT00242697

Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery

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.

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinal analgesia and anesthesia for coronary artery surgery

Procedure

Primary outcomes

  1. analgesic requirement in the intensive care unit

  2. visual analogue pain scores in the intensive care unit

  3. duration of endotracheal intubation in the intensive care unit

Secondary outcomes

  1. intraoperative hemodynamic variables

  2. intraoperative blood catecholamine and lactate levels

  3. intraoperative anesthetic supplementation

  4. intraoperative vasoactive drug therapy

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

A Randomized Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery

Important dates

Study start
2002
Study completion
2003
First posted
Oct 20, 2005
Registry last updated
Oct 20, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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