Inhaled Anesthetics and Myocardial Strain

NCT03569085 | Completed Phase 1 FDA Drug

• 1 other identifier: PRO17080624
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Diseases

Outcome Measures

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.

  Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass

Secondary Outcomes (2)

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

  Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass

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

  Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass

Study Arms (1)

Sevoflurane then isoflurane

EXPERIMENTAL

Drug: Sevoflurane; Drug: Isoflurane

Interventions

Sevoflurane DRUG

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.

Sevoflurane then isoflurane

Isoflurane DRUG

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.

Sevoflurane then isoflurane

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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) Contraindications to TEE examination such as recent esophageal surgery, esophageal cancer/stricture The use of anesthesia maintenance with intravenous anesthesia drugs such as propofol infusions

Sponsors & Collaborators

• Kathirvel Subramaniam: lead

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Sevoflurane; Isoflurane

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Kathirvel Subramaniam, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Same patients will receive two different arms/interventions and compared

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 26, 2018
• Study Start: June 27, 2018
• Primary Completion: December 6, 2018
• Study Completion: May 4, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

US (1)