The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

Seoul National University Hospital90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cerebral Oxygen Saturation

Interventions

PhenylephrineDRUG

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)

NorepinephrineDRUG

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)

VasopressinDRUG

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)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Cerebral oxygen saturation (%)

continuous monitoring of cerebral oxygen saturation during surgery

Time frame: during surgery

Secondary Outcomes

blood pressure

systolic/diastolic/mean blood pressure(mmHg)

Time frame: during surgery

heart rate

heart rate(/min)

Time frame: during surgery

cardiac index

cardiac index (L/min)

Time frame: during surgery

Total amount of infused drug

Propofol, remifentanil, vasoacitve drugs

Time frame: during surgery

Input/output

Urine output, blood loss, amount of fluid and transfusion

Time frame: during surgery

Sublingual microscopy

using SDF imaging device

Time frame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure

Vascular occlusion test

using InspectraTM StO2

Time frame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure

Troponin I

Troponin I (ng/mL)

Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission

Data from ClinicalTrials.gov

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