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Clinical trial

Effect of Inhalational Anesthetics on Myocardial Deformation Indices - A Dose-Response Cross-over Study

ID
Name
PRO17080624
Description
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.
Trial arms
Trial start
2018-06-27
Estimated PCD
2018-12-06
Trial end
2023-05-04
Status
Completed
Phase
Early phase I
Treatment
Sevoflurane
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.
Arms:
Sevoflurane then isoflurane
Isoflurane
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.
Arms:
Sevoflurane then isoflurane
Size
26
Primary endpoint
Global longitudinal strain of myocardium, unitless (Comparison between two inhalational anesthetics, isoflurane and sevoflurane)
Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass
Eligibility criteria
Inclusion Criteria: Adult Patients (\> 18 years of age) undergoing cardiovascular surgery at University of Pittsburgh Medical Center (UPMC) Presbyterian hospital. 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) 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Same patients will receive two different arms/interventions and compared', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}
Updated at
2023-10-05

1 organization

2 products

1 indication

Organization
Kathirvel Subramaniam
Product
Sevoflurane
Indication
Heart Diseases
Product
Isoflurane