Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)

February 19, 2018 updated by: Yunseok Jeon, Seoul National University Hospital
This study involves research using human subjects (cardiac surgical patients) to evaluate the effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied to upper or lower extremities has been shown cardioprotective role by lowering release of cardiac troponin in patients with cardiac diseases. However, it is not clear whether anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing cardiac surgery using cardiopulmonary bypass will be randomized to control, propofol, or sevoflurane group. Patients in the control group will receive remote ischemic preconditioning (RIPC) on their upper arms before anesthetic induction. Patients in the propofol or sevoflurane groups will receive RIPC after anesthetic induction using propofol or sevoflurane, respectively. In all patients, arterial blood samples will be obtained before and after each RIPC. From the samples, human dialysate will be obtained and perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Infarct size of the sectioned rat heart will be compared among the three - control, propofol, and sevoflurane - groups.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA class I~III patients undergoing cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

  • Cardiac surgery without using cardiopulmonary bypass
  • Descending thoracic aortic surgery
  • Strenuous exercise, excessive alcohol or caffeine intake 24 hours before remote ischemic preconditioning
  • Left ventricular ejection fraction < 30%
  • Uncontrolled hypertension or diabetes mellitus
  • Severe renal or hepatic dysfunction
  • Patients on hemodialysis
  • Patients with arterio-venous fistula on arms or any reason to protect arms
  • Peripheral vascular or nerve disease, bleeding tendency
  • Preoperative use of IABP, ECMO, or ventricular assist devices
  • Emergency operation, redo operation
  • Refuse to enroll
  • Pregnancy
  • Preoperative use of beta-blockers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic).
Other: Control
Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.
Other Names:
  • Not receiving any anesthetic
Active Comparator: Propofol
Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic.
Drug: Propofol
Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.
Other Names:
  • Receiving propofol anesthesia
Active Comparator: Sevoflurane
Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic.
Drug: Sevoflurane
Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.
Other Names:
  • Receiving sevoflurane anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size of the rat heart
Time Frame: 1 day after ischemia-reperfusion injury
1 day after ischemia-reperfusion injury

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac troponin I after surgery
Time Frame: 72 hours postoperatively
72 hours postoperatively
Major adverse cardiovascular and cerebrovascular events
Time Frame: Through study completion, average of 2 weeks before hospital discharge
Through study completion, average of 2 weeks before hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2017

Primary Completion (Actual)

February 7, 2018

Study Completion (Actual)

February 7, 2018

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPC_propofol
  • 1605-079-761 (Other Identifier: Seoul National University Hospital IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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