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

NCT01397331 | Terminated Phase 4

• 1 other identifier: SHEBA-09-7199-SP-CTIL
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

inhalational anesthesia; intravenous anesthesia; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in vascular tone and cardiac afterload

  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

• Changes of measures of global systolic left ventricular function

  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

Study Arms (2)

Inhalational anesthesia

ACTIVE COMPARATOR

Group of patients undergoing the surgery under anesthesia based on inhalational anesthetic

Drug: Isoflurane

TIVA

ACTIVE COMPARATOR

Group of patients undergoing the surgery under total intravenous anesthesia

Drug: Propofol

Interventions

Isoflurane DRUG

Anesthesia based on inhalation of 1-1.5 Minimal Alveolar Concentration of Isoflurane with the addition of infusion of remifentanil

Inhalational anesthesia

Propofol DRUG

Anesthesia based on the infusion of 2-5 mg/kg/h of propofol with the addition of infusion of remifentanil

TIVA

Eligibility Criteria

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

You may qualify if:

• Patients undergoing elective cardiac surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Department of Anesthesia and Intensive Care, Sheba Medical Center

Tel Hashomer, Ramat Gan, 52621, Israel

Location

MeSH Terms

Interventions

Isoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sergey Preisman, M.D.

  Department of Anesthesia and Intensive Care, Sheba Medical Center, Israel 52621

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 19, 2011
• Study Start: July 1, 2010
• Primary Completion: June 27, 2012
• Study Completion: June 27, 2012
• Last Updated: April 24, 2018

Record last verified: 2011-07

Locations

IL (1)