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

NCT00348920 | Completed DMC

• 1 other identifier: AOTSA1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

Aortic Valve; Aortic Stenosis; High Spinal Anesthesia; Total Spinal Anesthesia; Stress Response; Inflammatory Mediators; Renal Function; Hemodynamic Stability

Outcome Measures

Primary Outcomes (3)

• Stress response as measured by levels of circulating epinephrine, norepinephrine, and cortisol.

  Multiple time points

• Inflammatory response as measured by levels of circulating inflammatory mediators (e.g. interleukin-6, interleukin-8, interleukin-10, C-reactive protein, TNF-alpha).

  Multiple time points

• Blood glucose control (amount of insulin required to keep blood glucose 5-8 mmol/L). Renal function as measured by serum creatinine.

  Multiple time points

Secondary Outcomes (4)

• Vasopressor requirements to keep mean blood pressure between 60-80 mm Hg.

  Multiple time points

• Left ventricular wall motion score index as measured by TTE and TEE.

  Multiple time points

• 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.

  Multiple time points

• Time to extubation.

  Time of extubation

Study Arms (2)

1- General Anesthesia

NO INTERVENTION

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

2- High Spinal and General Anesthesia

EXPERIMENTAL

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

Procedure: High Spinal and General Anesthesia

Interventions

High Spinal and General Anesthesia PROCEDURE

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

Also known as: Bupivacaine, Epimorph

2- High Spinal and General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing surgery for aortic valve replacement due to aortic stenosis with or without CABG.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• St. Boniface Hospital: collaborator
• Health Sciences Centre Foundation, Manitoba: collaborator

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (4)

• 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.

  PMID: 12552211 BACKGROUND

• 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.

  PMID: 8850406 BACKGROUND

• 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.

  PMID: 16189338 BACKGROUND

• 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.

  PMID: 26930568 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Fractures, Stress

Interventions

Anesthesia, General; Bupivacaine

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Trevor WR Lee, MD

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

  PRINCIPAL INVESTIGATOR

• Stephen E Kowalski, MD

  Department of Anesthesia, Health Sciences Centre, University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Leader, Dept. of Anesth, St. Boniface Hospital

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: February 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 24, 2013

Record last verified: 2013-07

Locations

CA (1)