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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01397331
Other study ID # SHEBA-09-7199-SP-CTIL
Secondary ID
Status Terminated
Phase Phase 4
First received July 14, 2011
Last updated April 23, 2018
Start date July 1, 2010
Est. completion date June 27, 2012

Study information

Verified date July 2011
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms

  • Disorder; Heart, Functional, Postoperative, Cardiac Surgery
  • Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention

Drug:
Isoflurane
Anesthesia based on inhalation of 1-1.5 Minimal Alveolar Concentration of Isoflurane with the addition of infusion of remifentanil
Propofol
Anesthesia based on the infusion of 2-5 mg/kg/h of propofol with the addition of infusion of remifentanil

Locations

Country Name City State
Israel Department of Anesthesia and Intensive Care, Sheba Medical Center Tel Hashomer, Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of the relationship between left ventricular end-systolic elastance and effective arterial end-systolic elastance. 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 Changes in vascular tone and cardiac afterload arterial end-systolic elastance, left ventricular end-systolic stress 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 Changes of measures of global systolic left ventricular function left ventricular end-systolic elastance, systolic strain and strain rate, myocardial performance index, ejection fraction 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
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