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Completed

NCT Number: NCT02932722

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.

Other names: Not receiving any anesthetic

Propofol

Drug

Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.

Other names: Receiving propofol anesthesia

Sevoflurane

Drug

Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.

Other names: Receiving sevoflurane anesthesia

Primary outcomes

  1. Infarct size of the rat heart

    Time frame: 1 day after ischemia-reperfusion injury

Secondary outcomes

  1. Cardiac troponin I after surgery

    Time frame: 72 hours postoperatively

  2. Major adverse cardiovascular and cerebrovascular events

    Time frame: Through study completion, average of 2 weeks before hospital discharge

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2016
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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