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CTRI Number  CTRI/2025/12/099049 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 13/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check if cerebral oximetry monitoring helps in detecting mental decline after cardiac surgery 
Scientific Title of Study   Can cerebral oximetry helps in reducing the incidence of post operative cognitive dysfunction in patients undergoing cardiac surgery? 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chhavi Dwivedi 
Designation  Assistant Professor 
Affiliation  Superspeciality Hospital,NSCB Medical College 
Address  5th Floor,Room no. 1 Department of Anaesthesia, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College,Jabalpur(M.P)

Jabalpur
MADHYA PRADESH
482003
India 
Phone  9425385842  
Fax    
Email  drchhavitiwari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chhavi Dwivedi 
Designation  Assistant Professor 
Affiliation  Superspeciality Hospital,NSCB Medical College 
Address  5th Floor,Room No.1, Department of Anaesthesia, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College,Jabalpur,M.P

Jabalpur
MADHYA PRADESH
482003
India 
Phone  9425385842  
Fax    
Email  drchhavitiwari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chhavi Dwivedi 
Designation  Assistant Professor 
Affiliation  Superspeciality Hospital,NSCB Medical College 
Address  5th Floor,Room No.1, Department of Anaesthesia, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College,Jabalpur,M.P

Jabalpur
MADHYA PRADESH
482003
India 
Phone  9425385842  
Fax    
Email  drchhavitiwari@gmail.com  
 
Source of Monetary or Material Support  
Superspeciality Hospital,NSCB Medical College,Jabalpur 
 
Primary Sponsor  
Name  Netaji Subhash Chandra Bose Medical CollegeJabalpur 
Address  5th Floor,Room No.1, Department of Anaesthesia, Superspeciality Hospital, NSCB Medical College,Jabalpur 
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 
Chhavi Dwivedi  Superspeciality Hospital  5th floor,Room no.1, Department OF Anaesthesia, Superspeciality Hospital Netaji Subhash Chandra Bose Medical College,Jabalpur
Jabalpur
MADHYA PRADESH 
9425385842

drchhavitiwari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR(M.P.)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I342||Nonrheumatic mitral (valve) stenosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1)Patients undergoing elective cardiac surgery under CPB
2)Patients able to complete MoCA testing
3)ASA III-IV 
 
ExclusionCriteria 
Details  1)Pre-existing cognitive dysfunction or psychiatric illness
2)Visual or hearing impairment
3)Emergency surgery
4)Patient refusal  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To determine the incidence of Post-operative cognitive dysfunction using neurocognitive tests
2)To assess the correlation of intraoperative cerebral oximetry and incidence of Post operative cognitive dysfunction 
1)Baseline Montreal cognitive Assessment will be conducted 1 day before surgery.
2)Post-operative Cognitive Assessment performed on POD-5,day before discharge and three months after discharge
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate secondary outcome in relation to intraoperative cerebral desaturation episodes-
1)Post operative delirium
2)Duration of mechanical ventilation
3)Duration of ICU and hospital stay 
Post-operative delirium would be assessed on POD-5,A day before discharge 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Brief description of proposal

Introduction:

Postoperative cognitive dysfunction is a well-recognized complication following cardiac surgery, with reported incidence ranging from 30% to 80% depending on the timing and methods of assessment. POCD can lead to prolonged hospital stay, delayed rehabilitation, increased morbidity, and reduced quality of life. The etiology of POCD is multifactorial, with hypoperfusion, microemboli, systemic inflammatory response, and hypoxia contributing to its development during cardiopulmonary bypass and cardiac surgery.


Cerebral oximetry using near-infrared spectroscopy provides continuous, non-invasive monitoring of regional cerebral oxygen saturation, reflecting the balance between cerebral oxygen supply and demand. It has been proposed that intraoperative monitoring of cerebral oxygenation can help in the early detection of cerebral desaturation episodes, allowing timely interventions to prevent prolonged hypoxia and reduce neurological complications.


Several studies have indicated an association between intraoperative cerebral desaturation and the occurrence of POCD in patients undergoing cardiac surgery . Interventions to maintain cerebral oxygen saturation within 10-20 percent of baseline values during surgery have been shown to decrease the incidence of POCD and improve neurological outcomes.


Despite these findings, the role of cerebral oximetry in predicting and preventing POCD remains under evaluation, with variability in protocols, thresholds for intervention, and methods of cognitive assessment across studies]. Further investigation is warranted to determine whether cerebral oximetry-guided intraoperative management can effectively reduce the incidence and severity of POCD following cardiac surgery.


This study aims to evaluate the role of cerebral oximetry monitoring in cardiac surgery and its association with postoperative cognitive dysfunction in adult patients, contributing to the evidence for optimizing perioperative neurological outcome.

Aim:

To evaluate the role of intraoperative cerebral oximetry in reducing the  incidence of  post operative cognitive dysfunction in patients undergoing cardiac surgeries.

Primary Objective:

  • To determine the incidence of Post operative cognitive dysfunction using neurocognitive tests.
  • To assess the correlation of intra operative cerebral oximetry  and incidence of Post operative cognitive dysfunction


Secondary Objective:

  • To evaluate secondary outcomes 
    • Post operative delirium ,
    • duration of mechanical ventilation ,
    • duration of ICU and hospital stay,

 in relation to intraoperative cerebral desaturation episodes.

Justification: As neurological complications increase the morbidity  in cardiac and vascular surgeries, intra operative cerebral oximetry provides the opportunity to the clinician to use brain as an index organ for the adequacy of perfusion of other vital organs. 


Methodology:

Study Design:  Prospective randomized observational study. 


Place of work: Netaji Subhash Chandra Bose Medical College, Superspeciality Hospital, Jabalpur.

 

Sample Size:120 based on pilot study


Study Settings:

Cardiothoracic and Vascular Surgery operation theatres and Postoperative ICU.


Study Duration:18 months


Study Population:

Patients undergoing elective cardiac surgery under cardiopulmonary bypass.


Inclusion Criteria:

1) Age >18 years

2)Patients undergoing elective cardiac surgery under CPB.

3)Patients able to complete MoCA Testing

4)ASA III-IV



Exclusion Criteria:

1)Pre-existing cognitive dysfunction or psychiatric illness.

2)Visual or hearing impairment.

3)Emergency surgery.

4)Patient refusal.


Material and Methods: This study will be conducted at Superspeciality hospital,NSCB Medical college,Jabalpur,after approval from our institutional Ethics committee.This study will enroll 120 patients of ASA grade III and IV fulfilling the inclusion criteria undergoing elective Cardiac surgeries .The patients will be randomised into Group A and Group B with the help of computer generated randomized sequence.

GROUP A:Cerebral oximetry

GROUP B:Control 


1)Preoperative assessment

Baseline Montreal Cognitive Assessment will be conducted 1 day before surgery in a quiet environment.


2)Intraoperative Cerebral Oximetry Monitoring

Near-Infrared Spectroscopy cerebral oximeter sensors placed on the bilateral frontal region before induction.



Continuous monitoring of rSO2 throughout surgery including: 

Pre-induction

During CPB

Rewarming

Post-CPB until the end of surgery

Significant desaturation is defined as >20 percent drop from baseline or absolute regional oxygen saturation <50percent

Duration and number of any desaturation episodes will be recorded and treated as per the protocols. Interventions required for desaturation ,head position, FIO2 increase, CO2 adjustment, BP management will be documented.


Apart from standard ASA monitoring parameters, PaCO2, PaO2, hematocrit and MAP will be observed throughout the surgery.


Postoperative Cognitive Assessment: performed on POD-5 , day before discharge and 3 months after discharge in a quiet ,non-stimulating environment.




Delirium will be differentiated from POCD with the help of CAM-ICU Test


Data collection : data collection will be based on MoCA scale and rSO2 values.

Collected data will be analysed using Graphpad Prism version 10.4.2. continuous variables will be expressed as Mean ± SD and compared using Student- t test and Mann Whitney U test. Categorical variables will be analysed using Chi square And Fisher’s exact test, with statistical significance set at p<0.05.


 
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