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Remote Preconditioning and Myocardial Protection

NCT ID: NCT02877238

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-05-31

Brief Summary

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Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.

Detailed Description

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The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.

Conditions

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Congenital Heart Disease

Keywords

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remote ischemic preconditioning sevoflurane total intravenous anesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Sevoflurane plus remote ischemic preconditioning anesthesia will be induced and maintain with sevoflurane in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles

Group Type ACTIVE_COMPARATOR

Sevoflurane plus remote ischemic preconditioning

Intervention Type DRUG

Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning

Group B

anesthesia will be induced and maintain with total intravenous anesthesia (propofol, midazolam plus fentanyl) during plus remote ischemic preconditioning in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles

Group Type ACTIVE_COMPARATOR

Total intravenous anesthesia plus remote ischemic preconditioning

Intervention Type DRUG

Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning

Interventions

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Sevoflurane plus remote ischemic preconditioning

Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning

Intervention Type DRUG

Total intravenous anesthesia plus remote ischemic preconditioning

Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning

Intervention Type DRUG

Other Intervention Names

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Group A Group B

Eligibility Criteria

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Inclusion Criteria

* Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass

Exclusion Criteria

* Previous cardiac surgery
* Urgent or emergent cases
* Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sayed Kaoud Abd-Elshafy

Associate profossor of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sayed K Abd-Elshafy, MD

Role: PRINCIPAL_INVESTIGATOR

Associate professor of anesthesia

Locations

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Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IIRB0000871234

Identifier Type: -

Identifier Source: org_study_id