Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242697
Status:
COMPLETED
Last Update Posted:
2005-10-20
First Post:
2005-10-19
Brief Title:
Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Randomized Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 003 mgkg preoperatively and midazolam 003 mgkg 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 μgkg induction 1 μgkg x 2 prn mock spinal SO Sufentanil IV 02 μgkg induction 01 μgkg x 2 prn Spinal sufentanil 50 μg morphine 05 mg hyperbaric SL Sufentanil IV 02 μgkg induction 01 μgkg x 2 prn Spinal sufentanil 25 μg morphine 05 mg bupivacaine 975 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
METHODS
After IRB approval 63 consenting patients undergoing non-emergent coronary artery bypass grafting CABG entered a randomized double-blind trial Patients received lorazepam 003 mgkg preoperatively and midazolam 003 mgkg 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 μgkg induction 1 μgkg x 2 prn mock spinal SO Sufentanil IV 02 μgkg induction 01 μgkg x 2 prn Spinal sufentanil 50 μg morphine 05 mg hyperbaric SL Sufentanil IV 02 μgkg induction 01 μgkg x 2 prn Spinal sufentanil 25 μg morphine 05 mg bupivacaine 975 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None