The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

NCT ID: NCT04214145

Last Updated: 2022-05-09

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

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2021-09-03

Brief Summary

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The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting.

Detailed Description

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Conditions

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Cerebral Oxygen Saturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phenylephrine

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg \* 5@ + D5W 200 mL) if mean BP \< 60mmHg.

1. Initial rate: 0.42 μg/kg/min (=0.1 mL/kg/hr)
2. Increment by 0.21 μg/kg/min (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes
3. Maximum rate: 3.33 μg/kg/min (=0.8 mL/kg/hr)

Norepinephrine

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Continuous infusion of Norepienphrine 20 μg/mL (=NE 4mg \* 1@ + D5W 200 mL) if mean BP \< 60mmHg.

1. Initial rate: 0.03 μg/kg/min (=0.1 mL/kg/hr)
2. Increment by 0.015 μg/kg/min (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes
3. Maximum rate: 0.24 μg/kg/min (=0.8 mL/kg/hr)

Vasopressin

Group Type EXPERIMENTAL

Vasopressin

Intervention Type DRUG

Continuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u \* 1@ + D5W 200 mL) if mean BP \< 60mmHg.

1. Initial rate: 0.01 u/kg/hr (=0.1 mL/kg/hr)
2. Increment by 0.005 u/kg/hr (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes
3. Maximum rate: 0.08 u/kg/hr (=0.8 mL/kg/hr)

Interventions

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Phenylephrine

Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg \* 5@ + D5W 200 mL) if mean BP \< 60mmHg.

1. Initial rate: 0.42 μg/kg/min (=0.1 mL/kg/hr)
2. Increment by 0.21 μg/kg/min (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes
3. Maximum rate: 3.33 μg/kg/min (=0.8 mL/kg/hr)

Intervention Type DRUG

Norepinephrine

Continuous infusion of Norepienphrine 20 μg/mL (=NE 4mg \* 1@ + D5W 200 mL) if mean BP \< 60mmHg.

1. Initial rate: 0.03 μg/kg/min (=0.1 mL/kg/hr)
2. Increment by 0.015 μg/kg/min (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes
3. Maximum rate: 0.24 μg/kg/min (=0.8 mL/kg/hr)

Intervention Type DRUG

Vasopressin

Continuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u \* 1@ + D5W 200 mL) if mean BP \< 60mmHg.

1. Initial rate: 0.01 u/kg/hr (=0.1 mL/kg/hr)
2. Increment by 0.005 u/kg/hr (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes
3. Maximum rate: 0.08 u/kg/hr (=0.8 mL/kg/hr)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing off pump coronary artery bypass.

Exclusion Criteria

* Patient refusal
* Preoperative vasopressor use
* Preoperative mechanical circulatory support
* Concurrent cerebrovascular or head and neck surgery
* Technical difficulty of measuring brain oxygen saturation
* Redo coronary artery bypass surgery
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yunseok Jeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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OPCAB_vasopressor

Identifier Type: -

Identifier Source: org_study_id

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