NCT00242697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3 coronary-artery-disease

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
Last Updated

October 20, 2005

Status Verified

October 1, 2005

First QC Date

October 19, 2005

Last Update Submit

October 19, 2005

Conditions

Coronary Artery DiseaseCoronary Artery Bypass Surgery

Keywords

coronary artery bypass surgeryanesthesia, generalanesthesia, spinalheart-lung machine

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • intraoperative hemodynamic variables

  • intraoperative blood catecholamine and lactate levels

  • intraoperative anesthetic supplementation

  • intraoperative vasoactive drug therapy

Interventions

spinal analgesia and anesthesia for coronary artery surgeryPROCEDURE

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing non-emergent primary coronary artery bypass grafting using cardiopulmonary bypass

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Charles L MacAdams, MD FRCPC

    Department of Anesthesia, Foothills Medical Centre, University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 20, 2005

Study Start

April 1, 2002

Study Completion

July 1, 2003

Last Updated

October 20, 2005

Record last verified: 2005-10

Locations

CA(1)