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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Control
Propofol
Sevoflurane
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Propofol, Sevoflurane, Preconditioning

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Control

Propofol

Sevoflurane

Arm Description

Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic).

Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic.

Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic.

Outcomes

Primary Outcome Measures

Infarct size of the rat heart

Secondary Outcome Measures

Cardiac troponin I after surgery
Major adverse cardiovascular and cerebrovascular events

Full Information

First Posted
September 26, 2016
Last Updated
February 19, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02932722
Brief Title
Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)
Official Title
Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
February 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Propofol, Sevoflurane, Preconditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic).
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic.
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Not receiving any anesthetic
Intervention Description
Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Receiving propofol anesthesia
Intervention Description
Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Receiving sevoflurane anesthesia
Intervention Description
Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.
Primary Outcome Measure Information:
Title
Infarct size of the rat heart
Time Frame
1 day after ischemia-reperfusion injury
Secondary Outcome Measure Information:
Title
Cardiac troponin I after surgery
Time Frame
72 hours postoperatively
Title
Major adverse cardiovascular and cerebrovascular events
Time Frame
Through study completion, average of 2 weeks before hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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