The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

Not Applicable

Completed

• Conditions: Cerebral Oxygen Saturation
• Interventions: Drug: Phenylephrine; Drug: Vasopressin; Drug: Norepinephrine

• Registration Number: NCT04214145
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2019-12-22
• Study First Submitted QC: 2019-12-26
• Study First Posted: 2020-01-02
• Study Start: 2020-01-07
• Primary Completion: 2021-09-02
• Study Completion: 2021-09-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine	Phenylephrine	-
Vasopressin	Vasopressin	-
Norepinephrine	Norepinephrine	-

Primary Outcome Measures

Name	Time	Method
Cerebral oxygen saturation (%)	during surgery	continuous monitoring of cerebral oxygen saturation during surgery

Secondary Outcome Measures

Name	Time	Method
NGAL	during surgery, at ICU admission, 24 hours / 48 hours after ICU admission	NGAL (ng/mL)
MACCE	until 1 year after surgery	Major adverse cardiac and cerebrovascular events
blood pressure	during surgery	systolic/diastolic/mean blood pressure(mmHg)
heart rate	during surgery	heart rate(/min)
cardiac index	during surgery	cardiac index (L/min)
Total amount of infused drug	during surgery	Propofol, remifentanil, vasoacitve drugs
Sublingual microscopy	1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure	using SDF imaging device
Vascular occlusion test	1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure	using InspectraTM StO2
Troponin I	during surgery, at ICU admission, 24 hours / 48 hours after ICU admission	Troponin I (ng/mL)
lactate	during surgery, at ICU admission, 24 hours / 48 hours after ICU admission	lactate (mmol/L)
creatinine	during surgery, at ICU admission, 24 hours / 48 hours after ICU admission	creatinine (mg/dL)
albumin	during surgery, at ICU admission, 24 hours / 48 hours after ICU admission	albumin (g/dL)
AKI/RRT	until 1 year after surgery	renal complication
Input/output	during surgery	Urine output, blood loss, amount of fluid and transfusion

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of