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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932722
• Other study ID #: RIPC_propofol
• Secondary ID: 1605-079-761
• Status: Completed
• Phase: N/A
• First received: September 26, 2016
• Last updated: February 19, 2018
• Start date: February 22, 2017
• Est. completion date: February 7, 2018

Study information

• Verified date: February 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• Control
Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.

Drug:
• Propofol
Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.
• Sevoflurane
Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size of the rat heart		1 day after ischemia-reperfusion injury
Secondary	Cardiac troponin I after surgery		72 hours postoperatively
Secondary	Major adverse cardiovascular and cerebrovascular events		Through study completion, average of 2 weeks before hospital discharge