search
Back to results

The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery

Primary Purpose

Aortic Stenosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Spinal and General Anesthesia
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Stenosis focused on measuring Aortic Valve, Aortic Stenosis, High Spinal Anesthesia, Total Spinal Anesthesia, Stress Response, Inflammatory Mediators, Renal Function, Hemodynamic Stability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Undergoing surgery for aortic valve replacement due to aortic stenosis with or without CABG. Exclusion Criteria: INR > 1.4, PTT > 40 seconds platelet count < 80, 000 per microlitre local infection or deformity at the site of administration of the spinal anesthetic raised intracranial pressure or evolving neurological deficit at the time of surgery

Sites / Locations

  • St. Boniface General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1- General Anesthesia

2- High Spinal and General Anesthesia

Arm Description

General Anesthesia includes administration of a routine cardiac anesthetic as per institutional norms.

High Spinal and General Anesthesia includes a high dose intrathecal anesthetic administered prior to the induction of a standardized cardiac general anesthetic.

Outcomes

Primary Outcome Measures

Stress response as measured by levels of circulating epinephrine, norepinephrine, and cortisol.
Inflammatory response as measured by levels of circulating inflammatory mediators (e.g. interleukin-6, interleukin-8, interleukin-10, C-reactive protein, TNF-alpha).
Blood glucose control (amount of insulin required to keep blood glucose 5-8 mmol/L). Renal function as measured by serum creatinine.

Secondary Outcome Measures

Vasopressor requirements to keep mean blood pressure between 60-80 mm Hg.
Left ventricular wall motion score index as measured by TTE and TEE.
Hemodynamics including cardiac output and cardiac index, heart rate, systemic arterial and pulmonary arterial blood pressures, central venous pressure, and systemic and pulmonary vascular resistance.
Time to extubation.

Full Information

First Posted
July 5, 2006
Last Updated
July 22, 2013
Sponsor
University of Manitoba
Collaborators
St. Boniface Hospital, Health Sciences Centre Foundation, Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT00348920
Brief Title
The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery
Official Title
The Effects of High Spinal Anesthesia on Hemodynamics, Stress Response, Renal Function and Post-operative Pain Control in Patients Undergoing Aortic Valve Replacement for Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
St. Boniface Hospital, Health Sciences Centre Foundation, Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is looking at the effects of high spinal anesthesia (also known as total spinal anesthesia) combined with general anesthesia versus general anesthesia alone on the following: Stress response: Patients undergoing aortic valve replacement surgery have a large incision and a complex operation where they must be placed on the heart-lung machine. The body reacts to the heart-lung machine, increasing the stress response. High spinal anesthesia using local anesthetics when combined with general anesthesia has been shown to block some of the stress response to surgery and the response to the heart-lung machine. This study will examine if blood levels of stress hormones and also inflammatory mediators can be lowered with the use of high spinal anesthesia. Heart function: High spinal anesthesia in combination with general anesthesia may help the heart work better when there is a narrowed valve (aortic stenosis). The heart may also have improved ability to pump blood with this anesthetic technique. Lung function and post-operative pain control: After surgery, patients often have pain which prevents them from taking deep breaths and coughing. This can lead to pneumonia. This study will also examine if the post-operative pain relief provided by spinal morphine (given together with the spinal anesthetic) can provide any better pain control following surgery. By doing this, we want to see if patients can take bigger breaths after their surgery when spinal morphine is used, and try to prevent the complications that occur if patients are not able to breath deeply after surgery.
Detailed Description
It is hypothesized that high spinal anesthesia combined with general anesthesia decreases the intraoperative stress and inflammatory response and improve post-operative pain control and respiratory function in this patient population. It is also hypothesized that the technique will provide stable intraoperative hemodynamics during aortic valve replacement surgery. Stress response: Levels of hormones such as epinephrine, norepinephrine and cortisol are elevated during cardiac surgery and on the initiation of cardiopulmonary bypass. This stress response has previously been shown to be blunted with the use of high spinal anesthesia when combined with general anesthesia in coronary artery bypass surgery patients (Lee, Grocott, et al). Inflammatory response: In addition to the stress response there is also an accentuated inflammatory response. With contact of the patient's blood to the artificial bypass circuit, there is activation of various plasma protease pathways that generate multiple proinflammatory mediators. Complement levels and cytokine levels also rise. Clinical organ dysfunction involving the cardiovascular, pulmonary, renal and neurological systems can ultimately result. The effects of high spinal anesthesia on the inflammatory response that occurs with bypass have not been studied. Hemodynamics: It has previously been shown that high-spinal anesthesia for coronary artery bypass surgery provides stable intra-operative hemodynamics (Kowalewski, MacAdams, et al; Lee, Grocott, et al.). Although the use of spinal anesthesia in patients with aortic stenosis has been considered to be relatively contra-indicated, total spinal anesthesia may actually improve cardiac function by decreasing systemic afterload and increasing myocardial contractility. Post-operative analgesia and pulmonary function: The spinal administration of opioids, such as morphine, has been shown to improve post-operative pain management in patients having both cardiac and non-cardiac surgery (Jacobsohn, Lee, et al). Total spinal anesthesia with bupivacaine and spinal morphine combined with general anesthesia may also improve post-operative pain management and facilitate improved post-operative lung function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
Aortic Valve, Aortic Stenosis, High Spinal Anesthesia, Total Spinal Anesthesia, Stress Response, Inflammatory Mediators, Renal Function, Hemodynamic Stability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1- General Anesthesia
Arm Type
No Intervention
Arm Description
General Anesthesia includes administration of a routine cardiac anesthetic as per institutional norms.
Arm Title
2- High Spinal and General Anesthesia
Arm Type
Experimental
Arm Description
High Spinal and General Anesthesia includes a high dose intrathecal anesthetic administered prior to the induction of a standardized cardiac general anesthetic.
Intervention Type
Procedure
Intervention Name(s)
High Spinal and General Anesthesia
Other Intervention Name(s)
Bupivacaine, Epimorph
Intervention Description
Spinal bupivacaine 0.75% in dextrose, 6 mls (45mg) and preservative free morphine 3 mcg/kg (to a maximum of 300 mcg).
Primary Outcome Measure Information:
Title
Stress response as measured by levels of circulating epinephrine, norepinephrine, and cortisol.
Time Frame
Multiple time points
Title
Inflammatory response as measured by levels of circulating inflammatory mediators (e.g. interleukin-6, interleukin-8, interleukin-10, C-reactive protein, TNF-alpha).
Time Frame
Multiple time points
Title
Blood glucose control (amount of insulin required to keep blood glucose 5-8 mmol/L). Renal function as measured by serum creatinine.
Time Frame
Multiple time points
Secondary Outcome Measure Information:
Title
Vasopressor requirements to keep mean blood pressure between 60-80 mm Hg.
Time Frame
Multiple time points
Title
Left ventricular wall motion score index as measured by TTE and TEE.
Time Frame
Multiple time points
Title
Hemodynamics including cardiac output and cardiac index, heart rate, systemic arterial and pulmonary arterial blood pressures, central venous pressure, and systemic and pulmonary vascular resistance.
Time Frame
Multiple time points
Title
Time to extubation.
Time Frame
Time of extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing surgery for aortic valve replacement due to aortic stenosis with or without CABG. Exclusion Criteria: INR > 1.4, PTT > 40 seconds platelet count < 80, 000 per microlitre local infection or deformity at the site of administration of the spinal anesthetic raised intracranial pressure or evolving neurological deficit at the time of surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor WR Lee, MD
Organizational Affiliation
Department of Anesthesia and Perioperative Medicine, St. Boniface General Hospital, University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen E Kowalski, MD
Organizational Affiliation
Department of Anesthesia, Health Sciences Centre, University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12552211
Citation
Lee TW, Grocott HP, Schwinn D, Jacobsohn E; Winnipeg High-Spinal Anesthesia Group. High spinal anesthesia for cardiac surgery: effects on beta-adrenergic receptor function, stress response, and hemodynamics. Anesthesiology. 2003 Feb;98(2):499-510. doi: 10.1097/00000542-200302000-00032.
Results Reference
background
PubMed Identifier
8850406
Citation
Kowalewski R, MacAdams C, Froelich J, Neil S, Maitland A. Anesthesia supplemented with subarachnoid bupivacaine and morphine for coronary artery bypass surgery in a child with Kawasaki disease. J Cardiothorac Vasc Anesth. 1996 Feb;10(2):243-6. doi: 10.1016/s1053-0770(96)80246-1. No abstract available.
Results Reference
background
PubMed Identifier
16189338
Citation
Jacobsohn E, Lee TW, Amadeo RJ, Syslak PH, Debrouwere RG, Bell D, Klock PA, Tymkew H, Avidan M; University of Manitoba Health Sciences Centre Cardiac Anesthesia Group. Low-dose intrathecal morphine does not delay early extubation after cardiac surgery. Can J Anaesth. 2005 Oct;52(8):848-57. doi: 10.1007/BF03021781.
Results Reference
background
PubMed Identifier
26930568
Citation
Lee TW, Kowalski S, Falk K, Maguire D, Freed DH, HayGlass KT. High Spinal Anesthesia Enhances Anti-Inflammatory Responses in Patients Undergoing Coronary Artery Bypass Graft Surgery and Aortic Valve Replacement: Randomized Pilot Study. PLoS One. 2016 Mar 1;11(3):e0149942. doi: 10.1371/journal.pone.0149942. eCollection 2016.
Results Reference
derived

Learn more about this trial

The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery

We'll reach out to this number within 24 hrs