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CTRI Number  CTRI/2023/07/055738 [Registered on: 26/07/2023] Trial Registered Prospectively
Last Modified On: 12/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Regional Brain oxygen saturation Monitoring during CABG surgery and its correlation with Hematocrit, Mean BP and Partial pressure of Oxygen in blood 
Scientific Title of Study   Cerebral Oxygenation Monitoring during Coronary Artery Bypass Grafting and its correlation with Hematocrit, Mean Arterial Pressure and Partial pressure of Oxygen in arterial blood 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Indu Verma 
Designation  Senior Professor 
Affiliation  SMS Medical College 
Address  Department Of Anaesthesiology SMS Medical College

Jaipur
RAJASTHAN
302004
India 
Phone  9413622967  
Fax    
Email  dr.induverma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indu Verma 
Designation  Senior Professor 
Affiliation  SMS Medical College 
Address  Department Of Anaesthesiology SMS Medical College

Jaipur
RAJASTHAN
302004
India 
Phone  9413622967  
Fax    
Email  dr.induverma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jai Sharma 
Designation  Junior Resident 
Affiliation  SMS Medical College 
Address  Department Of Anaesthesiology SMS Medical College

Jaipur
RAJASTHAN
302004
India 
Phone  7015349027  
Fax    
Email  jays80425@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology, Dhanvantri Building, 2nd floor, SMS Medical College, Jaipur - 302004 
 
Primary Sponsor  
Name  SMS Medical College 
Address  SMS Medical College, JLN ROAD Jaipur 302004 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jai Sharma  SMS Medical College   Cardiothoracic Operation Theatre 1st Floor, SMS Medical College JLN Road -302004
Jaipur
RAJASTHAN 		 7015349027

jays80425@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS Medical College, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient willing to give consent
2. American Society of Anaesthesiologists (ASA) grade II - III
3. Patient’s body weight 40-70 Kgs
4. Patients undergoing Coronary Artery Bypass Grafting surgery
 
 
ExclusionCriteria 
Details  1. Emergency surgery
2. Evidence of carotid disease
3. History of cerebrovascular accident or syncope
4. Evidence of any liver or kidney disease
5. Acute coronary syndrome
6. Severe uncontrolled hypertension (MAP>150 mmHg)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• Mean regional oxygen saturation of right side of frontal lobe [rSo2R]
• Mean regional oxygen saturation of left side of frontal lobe [rSo2L]
• Mean haematocrit
• Mean arterial blood pressure [MAP]
• Mean partial pressure of oxygen in arterial blood [PaO2]
• Mean cardiopulmonary bypass flows [CPB flows] 		 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 Outcome  
Outcome  TimePoints 
Use Of ionotropes  Intraoperatively 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2023 
Date of Study Completion (India) 30/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Coronary Artery Bypass Grafting (CABG) is a widely performed surgical procedure aimed at restoring blood flow to the heart muscles by bypassing obstructed or narrowed coronary arteries. Despite advancements in surgical techniques and perioperative care, cerebral complications during and after CABG surgery remain a significant concern.Near-infrared spectroscopy (NIRS) is also non-invasive monitoring technique that measures regional cerebral oxygen saturation (rSO2) and provides insights into cerebral oxygenation. By shining near-infrared light into the scalp and measuring the reflected light, NIRS allows continuous monitoring of regional oxygenation in real-time. NIRS optode contains an infrared light source which is transmitted through the skull to the outer layer of the cerebral cortex. The same optode has different sensors which distinguish between the photons reflected from skin, muscle, skull, dura and brain.  
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