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Clinical Trials/CTRI/2023/07/055738
CTRI/2023/07/055738CompletedNot Applicable

Cerebral Oxygenation Monitoring during Coronary Artery Bypass Grafting and its correlation with Hematocrit, Mean Arterial Pressure and Partial pressure of Oxygen in arterial blood

SMS Medical College1 site in 1 country72 target enrollmentStarted: January 9, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
72
Locations
1
Primary Endpoint
• Mean regional oxygen saturation of right side of frontal lobe [rSo2R]

Study Overview

Brief Summary

Coronary Artery Bypass Grafting (CABG) is a widelyperformed surgical procedure aimed at restoring blood flow to the heart musclesby bypassing obstructed or narrowed coronary arteries. Despite advancements insurgical techniques and perioperative care, cerebral complications during andafter CABG surgery remain a significant concern.Near-infrared spectroscopy (NIRS) is alsonon-invasive monitoring technique that measures regional cerebral oxygensaturation (rSO2) and provides insights into cerebral oxygenation. By shiningnear-infrared light into the scalp and measuring the reflected light, NIRSallows continuous monitoring of regional oxygenation in real-time. NIRS optodecontains an infrared light source which is transmitted through the skull to theouter layer of the cerebral cortex. The same optode has different sensors whichdistinguish between the photons reflected from skin, muscle, skull, dura andbrain.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient willing to give consent
  • American Society of Anaesthesiologists (ASA) grade II.
  • Patient’s body weight 40-70 Kgs
  • Patients undergoing Coronary Artery Bypass Grafting surgery.

Exclusion Criteria

  • Emergency surgery
  • Evidence of carotid disease
  • History of cerebrovascular accident or syncope
  • Evidence of any liver or kidney disease
  • Acute coronary syndrome
  • Severe uncontrolled hypertension (MAP>150 mmHg).

Outcomes

Primary Outcomes

• Mean regional oxygen saturation of right side of frontal lobe [rSo2R]

Time Frame: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean regional oxygen saturation of left side of frontal lobe [rSo2L]

Time Frame: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean haematocrit

Time Frame: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean arterial blood pressure [MAP]

Time Frame: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean partial pressure of oxygen in arterial blood [PaO2]

Time Frame: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean cardiopulmonary bypass flows [CPB flows]

Time Frame: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

Secondary Outcomes

  • Use Of ionotropes(Intraoperatively)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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