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Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397331
First Posted: July 19, 2011
Last Update Posted: July 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
The aim of the study is to delineate and compare the changes in coupled mechanical properties of left ventricle and arterial vascular bed caused by two popular anesthetic protocols commonly used in cardiac surgery (intravenous, based on the infusion of propofol, versus inhalational, based on isoflurane) on different stages of the surgery.

Condition Intervention Phase
Heart; Dysfunction Postoperative, Cardiac Surgery Disorder; Heart, Functional, Postoperative, Cardiac Surgery Drug: Isoflurane Drug: Propofol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Changes of the relationship between left ventricular end-systolic elastance and effective arterial end-systolic elastance. [ Time Frame: 15 minutes and 30 minutes after the induction of anesthesia in Inhalational Group and TIVA Group respectively, 15 minutes after the separation from cardiopulmonary bypass, and before the transfer of the patient to the Intensive Care Unit in both groups ]

Secondary Outcome Measures:
  • Changes in vascular tone and cardiac afterload [ Time Frame: 15 minutes and 30 minutes after the induction of anesthesia in Inhalational Group and TIVA Group respectively, 15 minutes after the separation from cardiopulmonary bypass, and before the transfer of the patient to the Intensive Care Unit in both groups ]
    arterial end-systolic elastance, left ventricular end-systolic stress

  • Changes of measures of global systolic left ventricular function [ Time Frame: 15 minutes and 30 minutes after the induction of anesthesia in Inhalational Group and TIVA Group respectively, 15 minutes after the separation from cardiopulmonary bypass, and before the transfer of the patient to the Intensive Care Unit in both groups ]
    left ventricular end-systolic elastance, systolic strain and strain rate, myocardial performance index, ejection fraction


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Inhalational anesthesia
Group of patients undergoing the surgery under anesthesia based on inhalational anesthetic
Drug: Isoflurane
Anesthesia based on inhalation of 1-1.5 Minimal Alveolar Concentration of Isoflurane with the addition of infusion of remifentanil
Active Comparator: TIVA
Group of patients undergoing the surgery under total intravenous anesthesia
Drug: Propofol
Anesthesia based on the infusion of 2-5 mg/kg/h of propofol with the addition of infusion of remifentanil

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective cardiac surgery

Exclusion Criteria:

  • Emergent surgery.
  • History of previous cardiac surgery.
  • Significant arrhythmias.
  • More than trivial valvular disorder.
  • Absence of written informed consent.
  • Contraindications for transesophageal echocardiography.
  • Pregnant women.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397331


Contacts
Contact: Sergey Preisman, M.D. +972-3-5302754 Sergey.Preisman@sheba.health.gov.il
Contact: Eduard Amlinsky, M.D. +972-3-5302754 eduard.amlinsky@gmail.com

Locations
Israel
Department of Anesthesia and Intensive Care, Sheba Medical Center Recruiting
Tel Hashomer, Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Sergey Preisman, M.D. Department of Anesthesia and Intensive Care, Sheba Medical Center, Israel 52621
  More Information

Responsible Party: Sergey Preisman, M.D., Department of Anesthesia and Intensive Care, Sheba Medical Center, Tel Hashomer, Israel 52621
ClinicalTrials.gov Identifier: NCT01397331     History of Changes
Other Study ID Numbers: SHEBA-09-7199-SP-CTIL
First Submitted: July 14, 2011
First Posted: July 19, 2011
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by Sheba Medical Center:
inhalational anesthesia
intravenous anesthesia
cardiac surgery

Additional relevant MeSH terms:
Anesthetics
Propofol
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation


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