Post Spinal Hemodynamic Changes in Aortic Stenosis and Mitral Regurgitation by VIS Index and Echocardiography

NCT06156592 | Completed

• 1 other identifier: HS25925
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess hemodynamic changes induced after spinal anesthesia by evaluating vasopressor inotropic requirements and variations in echocardiographic parameters in patients having severe aortic stenosis or severe mitral regurgitation undergoing aortic or mitral valve replacement surgery.

Conditions

Severe Aortic Valve Stenosis; Severe Mitral Valve Regurgitation

Keywords

mitral valve replacement; aortic valve replacement; spinal anesthesia; echocardiographic monitoring; aortic stenosis; mitral regurgitation

Outcome Measures

Primary Outcomes (3)

• To compare total inotropic, inodilators and vasopressor drug requirements by calculating the vasoactive-inotropic score (VIS) Index to maintain target stable hemodynamics in both groups

  Total modified VIS score (pre CPB or on CPB or post CPB) = (total dopamine in mcg ) + (total dobutamine in mcg) + (10 x total milrinone in mcg) + (10,000 x total vasopressin unit) + (100 x total norepinephrine in mcg) + ( 100 x total epinephrine dose mcg) + (100 x total ephedrine dose in mg) VIS index = Total modified VIS score / (weight in Kg x time in minutes)

  From spinal drug injection to the starting of cardiopulmonary bypass (CPB), during CPB surgery and post CPB up to the time when patient leaves operation room

• To compare changes in right and left ventricular myocardial performance index (Tei) in both groups

  Tei index for the left ventricle will be derived using Doppler interrogation MV and left ventricular outflow tract (LVOT) blood flows and for both RV and LV by tissue Doppler interrogation of TV and MV lateral annular plane motion on echocardiography in both groups

  Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up

• To compare changes in Left Ventricular Outflow Tract (LVOT) Cardiac Index (CI) in both groups

  LVOT cardiac index will be derived pulse wave Doppler interrogation of LVOT flow, 2 dimensional LVOT area and heart rate by echocardiography

  Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up

Secondary Outcomes (6)

• Subgroup analysis of patients with preserved Left Ventricular Ejection Fraction (LVEF) and reduced LVEF for comparison of Tei index of right ventricle, and left ventricle, TAPSE, MAPSE and LVOT CI by echocardiography and VIS index to maintain target he

  Similar pre-defined time points for echocardiography readings and VIS index durations as for primary end points.

• Assessment and determination of changes in other echocardiographic hemodynamic parameters of preload, after load after high spinal anesthesia in severe AS and severe MR and their comparison to baseline and between these two valvular pathologies.

  Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up

• Assessment and determination of changes in other echocardiographic parameters of RV contractility after high spinal anesthesia in severe AS and severe MR and their comparison to baseline and between these two valvular pathologies.

  Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up

• Assessment and determination of changes in other echocardiographic parameters of LV contractility after high spinal anesthesia in severe AS and severe MR and their comparison to baseline and between these two valvular pathologies.

  Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up

• Comparison of pulse oximetry and cerebral oximetry changes during study period between AS and MR patients

  Baseline, at echo reading time points, and every 15 minutes afterwards to the end of surgery in both the groups

Study Arms (2)

Severe aortic stenosis group

Patients with severe aortic stenosis who are undergoing open aortic valve replacement under high spinal in combination with light general anesthesia.

Procedure: Cardiac valve replacement surgery under high spinal anesthesia combined with light general anesthesia

Severe mitral regurgitation group

Patients with severe mitral regurgitation who are undergoing open mitral valve replacement under high spinal in combination with light general anesthesia.

Procedure: Cardiac valve replacement surgery under high spinal anesthesia combined with light general anesthesia

Interventions

Cardiac valve replacement surgery under high spinal anesthesia combined with light general anesthesia PROCEDURE

Before induction of general anesthesia, a high spinal anesthesia will be given using 37.5 mg of 0.75% heavy bupivacaine with 20 mcg fentanyl and 250 mcg epimorphine in sitting position at the lumbar intervertebral spaces between the L2-3 or L3-4 vertebrae. Patients will lie supine immediately afterwards, and sensory loss to ice will be performed every 15 seconds. Subsequently, the patient will be placed in 15-degree Trendelenburg (ensured by clinometer). Following general anesthesia will be induced and trachea will be intubated after 5 ml of 4% lignocaine spray on vocal cords and trachea. Hemodynamics will be aimed at MAP between 65-100 mmHg and heart rate between 50-100 beats /min by use of various inotropic, inodilators and vasoactive cardiac drugs based on anesthesiologists' clinical judgement.

Severe aortic stenosis group; Severe mitral regurgitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to St. Boniface Hospital, Winnipeg, Canada, a tertiary care hospital, for elective aortic or mitral valve repair over the period Oct 2023 to December 2025.

You may qualify if:

• All patients over 18 years of age, irrespective of their gender or ASA physical status
• With severe aortic stenosis or mitral regurgitation
• Undergoing elective aortic or mitral valve repair or replacement
• Eligible for spinal anesthesia up to T1-2 level block for their surgical procedure.
• Able to provide written informed consent

You may not qualify if:

• Contraindications to the administration of spinal anesthesia such as pre-existing coagulopathy, local sepsis at the site of insertion
• Hypoxic (SaO2 \< 95%) on room air
• Unable to lie flat and with 15-degree trendelenburg
• The apical four and five chamber window is not accessible on trans-thoracic echocardiography
• Difficult airway requiring awake intubation
• On dialysis
• Redo-valve surgery
• Mixed valvular lesions (more than mild AR or MS)
• Requiring more than one CABG or CPB duration more than 180 minutes
• More than 3 segment Regional Wall Motion Abnormalities
• Severe spine disorders

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Department of Anesthesiology, Perioperative and Pain Medicine, SBGH

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (9)

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  PMID: 28515514 BACKGROUND

• Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or placebo infusion. Anesthesiology. 2008 Nov;109(5):856-63. doi: 10.1097/ALN.0b013e31818a401f.

  PMID: 18946298 BACKGROUND

• Bhat I, Arya VK, Mandal B, Jayant A, Dutta V, Rana SS. Postoperative hemodynamics after high spinal block with or without intrathecal morphine in cardiac surgical patients: a randomized-controlled trial. Can J Anaesth. 2021 Jun;68(6):825-834. doi: 10.1007/s12630-021-01937-z. Epub 2021 Feb 9.

  PMID: 33564993 BACKGROUND

• Arya VK, Al-Moustadi W, Dutta V. Cardiac output monitoring - invasive and noninvasive. Curr Opin Crit Care. 2022 Jun 1;28(3):340-347. doi: 10.1097/MCC.0000000000000937. Epub 2022 Mar 11.

  PMID: 35275876 BACKGROUND

• Tei C, Ling LH, Hodge DO, Bailey KR, Oh JK, Rodeheffer RJ, Tajik AJ, Seward JB. New index of combined systolic and diastolic myocardial performance: a simple and reproducible measure of cardiac function--a study in normals and dilated cardiomyopathy. J Cardiol. 1995 Dec;26(6):357-66.

  PMID: 8558414 BACKGROUND

• Cheng DC. Fast track cardiac surgery pathways: early extubation, process of care, and cost containment. Anesthesiology. 1998 Jun;88(6):1429-33. doi: 10.1097/00000542-199806000-00002. No abstract available.

  PMID: 9637632 BACKGROUND

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

  PMID: 25559473 BACKGROUND

• Poulsen SH, Nielsen JC, Andersen HR. The influence of heart rate on the Doppler-derived myocardial performance index. J Am Soc Echocardiogr. 2000 May;13(5):379-84. doi: 10.1016/s0894-7317(00)70007-1.

  PMID: 10804435 BACKGROUND

• Su HM, Lin TH, Hsu PC, Chu CY, Lee WH, Lee CS, Lai WT, Sheu SH, Voon WC. Myocardial performance index derived from preejection period: a novel and feasible parameter in evaluation of cardiac performance in patients with permanent atrial fibrillation. Echocardiography. 2011 Nov;28(10):1081-7. doi: 10.1111/j.1540-8175.2011.01491.x. Epub 2011 Aug 19.

  PMID: 22077881 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Virendra Arya, MD, FRCPC

  SBGH, University of Manitoba, Winnipeg, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: December 5, 2023
• Study Start: November 1, 2023
• Primary Completion: October 26, 2025
• Study Completion: October 26, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)