Comparison of the relationship between cerebral oxygen saturation and mild hypercapnia in patients undergoing off- pump Coronary Artery Bypass Grafting

Not yet recruiting

Conditions: Atherosclerosis of other arteries, (2) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere,

Registration Number: CTRI/2022/04/042240

Lead Sponsor: UNMICRC

Brief Summary: A thorough pre-anaesthetic check-up will be done prior to surgery. Patients will be educated briefly about the anaesthesia procedure. All patients will be kept nil by mouth for 6 hours prior to surgery. Written and informed consent will be taken from all patients participating in the study. Patientâ€™s confidentiality will be maintained at all times and patients will be duly informed about the study through patient information sheet before signing the informed consent.

On arrival to the operating room, monitors including five lead electrocardiogram, pulse oximeter , capnography will be connected. An intravenous access with 16G/18G cannula and a radial arterial line under local anaesthesia shall be achieved for IABP monitoring and for ABG sampling. Prior to induction of anaesthesia, cerebral oximetry sensors placed bilaterally over the fronto temporal area, and the baseline rSO2 values will be measured. The patient shall be given Inj Midazolam 0.3mg/kg, Inj Fentanyl 5-10 microgram/kg body weight and Inj vecuronium 0.1 mg/kg body weight shall be used for induction. The patient will be pre oxygenated for 3 minutes and then intubated with appropriate size endotracheal Tube. A 7 fr central line will be secured for administration of drugs (infusion of Dobutamine /Milirinone, Noradrenaline, Nitroglycerine) and for CVP monitoring. Anaesthesia will be maintained with fentanyl and sevoflurane in oxygen, air mixture. Muscle relaxant will be maintained with vecuronium boluses.

After induction patient will be randomised to either targeted mild hypercapnia (TMH) or targeted normocapnia (TN) group. Minute ventilation will be adjusted to maintain an end tidal carbon dioxide concentration of 45-55 mm Hg just before LIMA harvesting in targeted mild hypercapnia (TMH) group and 35-40 mm Hg in targeted normocapnia (TN) group. Inj heparin 100 units/kg to maintain ACT level around 250.The fluid will be given as per CVP . The ionotrope will be decided by pre op or intra op condition of heart and hemodynamics.

The cerebral oxygen saturation (rSO2), heart rate (HR), Mean Arterial Pressure (MAP), end tidal CO2, , peripheral oxygen saturation (SPO2) monitoring done as baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU. ABG will be taken before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting to ICU, 4,12, 24 hrs and 48 hrs after extubation. The Standardized Mini-Mental State Examination (SMMSE) will be performed preoperatively, at 8, 12 & 24 hrs post-extubation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

OPCABG, EF>40%.

Exclusion Criteria

PATIENTS ON ECMO OR IABP, REDO CABG SURGERY.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the relationship between mild hypercapnia and regional cerebral oxygen saturation (rSo2) during off -pump CABG.	baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU?

Secondary Outcome Measures

Name	Time	Method
To observe intraoperative pH, bicarbonate concentration, serum potassium concentration and incidence of postoperative cognitive dysfunction.	baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU, 4 hrs, 12 hrs and 24 hrs

Trial Locations

Locations (1): U.N.Mehta Institute of Cardology and research center
🇮🇳
Ahmadabad, GUJARAT, India
U.N.Mehta Institute of Cardology and research center
🇮🇳Ahmadabad, GUJARAT, India
Dr Hemang Gandhi
Principal investigator
9404552355
drhemang77@gmail.com