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

NCT ID: NCT00348920

Last Updated: 2013-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2013-07-31

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.

Conditions

Aortic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1- General Anesthesia

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

2- High Spinal and General Anesthesia

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

Group Type: EXPERIMENTAL

High Spinal and General Anesthesia

Intervention Type: PROCEDURE

Spinal bupivacaine 0.75% in dextrose, 6 mls (45mg) and preservative free morphine 3 mcg/kg (to a maximum of 300 mcg).

Interventions

High Spinal and General Anesthesia

Spinal bupivacaine 0.75% in dextrose, 6 mls (45mg) and preservative free morphine 3 mcg/kg (to a maximum of 300 mcg).

Intervention Type: PROCEDURE

Other Intervention Names

Bupivacaine; Epimorph

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Boniface Hospital

OTHER

Sponsor Role: collaborator

Health Sciences Centre Foundation, Manitoba

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Trevor William R. Lee

Site Leader, Dept. of Anesth, St. Boniface Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trevor WR Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Perioperative Medicine, St. Boniface General Hospital, University of Manitoba

Stephen E Kowalski, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Health Sciences Centre, University of Manitoba

Locations

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 12552211 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8850406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16189338 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26930568 (View on PubMed)

Other Identifiers

AOTSA1

Identifier Type: -

Identifier Source: org_study_id