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CompletedNCT03569085Updated Oct 5, 2023

Inhaled Anesthetics and Myocardial Strain

A Phase 1 interventional study of Sevoflurane and Isoflurane in Heart Diseases, sponsored by Kathirvel Subramaniam. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Kathirvel Subramaniam · Phase 1, Interventional, and Screening

From the registry’s dates

  • Primary completion was Dec 2018, 7 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Speckle tracking imaging measuring software will be used for offline analysis of transesophageal echocardiogram (TEE) -acquired images of the left ventricle(LV) in four chambers(4C), two chambers (2C) and long axis (LAX) views to calculate global longitudinal strain (GLS) of LV for comparisons between sevoflurane and isoflurane at the same minimum alveolar concentration ( MAC) levels.

Read the detailed description

The primary research activity will be: baseline transthoracic echocardiogram (TTE) views taken upon the patient entering the operating room by one of the cardiothoracic anesthesiology fellows or attendings, TEE views taken by the echocardiography fellow or attending in the mid-esophageal 4C, 2C and LAX views once the patient has reached sevoflurane end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5. Following this, sevoflurane will be changed to isoflurane and wait till complete washout of sevoflurane (i.e. end-tidal sevoflurane concentration reaches zero). Isoflurane concentration will be adjusted according to bispectral index and hemodynamics to maintain anesthesia during this period. Once complete sevoflurane wash-out has been achieved, isoflurane concentration will be adjusted and repeat images taken at the 0.5, 1.0, and 1.5 MAC values.

Investigators will establish stability at each MAC level (0.5, 1.0 and 1.5) for 5 minutes before obtaining TEE images. The whole study is done during pre- cardiopulmonary bypass(CPB) period while surgeon spending time dissecting internal mammary artery or other parts of surgical dissection before heparinization. The entire study duration will be a maximum of 35-40 minutes and this will not prolong the operating time. The adjustment of the anesthetic will be performed by the cardiac anesthesiology fellow or senior resident involved in this research along with the faculty officially performing the case. All images will be acquired prior to the initiation of cardiopulmonary bypass by the echocardiography rotating resident or research resident, cardiac anesthesiology fellow or cardiac anesthesiology attending anesthesiologist (all received extensive training in TEE to obtain those required images). Following the completion of the case and the uploading of images to a central echocardiography server, one of the study personnel will perform analysis of the images in the anesthesiology offices on a computer with post-processing software to determine strain.

MAC up to 1.5 is very well tolerated in cardiac surgical patients and is routinely used to achieve hemodynamic conditions during surgery. Use of vasopressor and inotrope to allow maintain depth of anesthesia with inhalation anesthesia agents is also routine in cardiac surgical patients and not in any way different from routine clinical care.

Hemodynamic information (heart rate, blood pressure, central venous pressure, cardiac index or pulmonary artery pressure) will be obtained after stabilization with each MAC and will be recorded immediately or extracted from the electronic medical records.

02

Conditions studied

  • Heart Diseases

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03

In context

Heart Diseases

2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.

This study's enrollment of 26 is below the median of 129 across 931 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Kathirvel Subramaniam is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adult Patients (> 18 years of age) undergoing cardiovascular surgery at University of Pittsburgh Medical Center (UPMC) Presbyterian hospital.

Exclusion criteria

Exclusion Criteria:

Inability to comprehend and understand the study, Pregnancy Malignant hyperthermia Acute cardiogenic shock and ongoing chest pain Permanent pacemaker with pacemaker dependency Abnormal cardiac rhythms ( e.g. atrial fibrillation) to TEE examination such as recent esophageal surgery, esophageal cancer/stricture The use of anesthesia maintenance with intravenous anesthesia drugs such as propofol infusions

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Sevoflurane then isoflurane

    Drug: Sevoflurane · Drug: Isoflurane

Interventions

  • The patient will receive Sevoflurane in incremental doses titrated to obtain end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5.

  • The patient will receive isoflurane in incremental doses titrated to obtain end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5.

06

What researchers measure

Primary outcomes

  1. Global longitudinal strain of myocardium, unitless (Comparison between two inhalational anesthetics, isoflurane and sevoflurane)

    Global longitudinal Strain measures changes in longitudinal length of myocardium and is a unitless measure. TEE images will be taken during surgery, stored on central echocardiography server, then analyzed offline using a special software to calculate global longitudinal strain (GLS). GLS of LV will then be compared between isoflurane and sevoflurane at the same MAC concentrations.

    Time frame: Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass

Secondary outcomes

  1. Global longitudinal strain of myocardium, unitless (Dose dependent effect of sevoflurane)

    Global longitudinal Strain measures changes in longitudinal length of myocardium and is a unitless measure. TEE images will be taken during surgery, stored on central echocardiography server, then analyzed offline using a special software to calculate global longitudinal strain (GLS). GLS of LV will then be compared at increasing MAC of sevoflurane.

    Time frame: Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass

  2. Global longitudinal strain of myocardium, unitless (Dose dependent effect of isoflurane)

    Global longitudinal Strain measures changes in longitudinal length of myocardium and is a unitless measure. TEE images will be taken during surgery, stored on central echocardiography server, then analyzed offline using a special software to calculate global longitudinal strain (GLS). GLS of LV will then be compared at increasing MAC of isoflurane.

    Time frame: Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass

07

Study locations

1 site
  • UPMC Presbyterian Hospital
    Pittsburgh, Pennsylvania 15213, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Dec 2018, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2018
First posted
Jun 26, 2018
StartActual
Jun 27, 2018
Primary completionActual
Dec 6, 2018
CompletionActual
May 4, 2023
Last update
Oct 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03569085
Lead sponsor
Kathirvel Subramaniam
Responsible party
Kathirvel Subramaniam (Associate Professor, University of Pittsburgh) — Sponsor-investigator
First posted
Jun 26, 2018
Start date
Jun 27, 2018
Primary completion
Dec 6, 2018
Completion
May 4, 2023
Last update
Oct 5, 2023

Study contacts

Kathirvel Subramaniam, MD, MSc
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Sevoflurane · Isoflurane

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