Cerebral Oxygen Saturation
Conditions
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.
Interventions
DRUGPhenylephrine
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)
DRUGNorepinephrine
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)
DRUGVasopressin
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)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral oxygen saturation (%) | during surgery | continuous monitoring of cerebral oxygen saturation during surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Input/output | during surgery | Urine output, blood loss, amount of fluid and transfusion |
| 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 |
| blood pressure | during surgery | systolic/diastolic/mean blood pressure(mmHg) |
| 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) |
| 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 |
| AKI/RRT | until 1 year after surgery | renal complication |
| Troponin I | during surgery, at ICU admission, 24 hours / 48 hours after ICU admission | Troponin I (ng/mL) |
Countries
South Korea
Outcome results
None listed