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CTRI Number  CTRI/2025/07/091174 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Assessing pain and decline in brain function after surgery in participants undergoing coronary artery bypass graft surgery with respect to anxiety level before surgery 
Scientific Title of Study   An observational study to evaluate postoperative pain and neurocognitive decline in patients undergoing coronary artery bypass graft surgery with or without significant preoperative anxiety at SMS Medical College Jaipur 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reema Meena 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College,Jaipur 
Address  Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Rajasthan 302001 India

Jaipur
RAJASTHAN
302001
India 
Phone  9413237117  
Fax    
Email  reemadr.rn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reema Meena 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College,Jaipur 
Address  Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Rajasthan 302001 India


RAJASTHAN
302001
India 
Phone  9413237117  
Fax    
Email  reemadr.rn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ranu Gandhi 
Designation  Pg Student 
Affiliation  Sawai Man Singh Medical College,Jaipur 
Address  Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Rajasthan 302001 India

Jaipur
RAJASTHAN
302001
India 
Phone  9460941901  
Fax    
Email  ranugandhi5747@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, SMS Medical College, Jaipur 
 
Primary Sponsor  
Name  Sawai Mansingh Medical College and Hospital 
Address  Department of Anesthesiology, Second Floor, Dhanvantri OPD block, SMS Hospital, Jaipur 
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 Reema Meena  SMS Hospital   Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Rajasthan 302001 India
Jaipur
RAJASTHAN 		 09413237117

reemadr.rn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Ethics Committee,SMS Medical College and attached hospitals, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients giving informed written consent. 2. Aged between 18 to 65 years 3. Patients with ASA grade class II to III undergoing elective coronary artery bypass graft surgery. 4. Subjects capable of answering Amsterdam preoperative anxiety and information scale questionnaire.  
 
ExclusionCriteria 
Details  1. Patients who had undergone prior cardiothoracic procedure. 2. Participants giving history of opioid addiction. 3. Patients with other comorbidities. 4. Patients with any type of psychiatric illness or delirium before surgery. 5.Patients taking part in any other study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) To assess and compare the postoperative visual analogue score in two groups
2) To determine the difference in the consumption of fentanyl post operatively between the two groups
3) To assess and compare the neuro cognitive function between the two groups
 		 1) To assess the visual analogue score at 15 minutes and then 3,6,12, 18, 24, 30, 36, 42, 48 hours after extubation
2) To determine total dose of fentanyl within 48 hours after extubation.
3) To assess the neuro cognitive function by mini mental State examination on post op day 1, 2, 3 and 4. 
 
Secondary Outcome  
Outcome  TimePoints 
1)To assess and compare the hemodynamic parameters between the two groups.
2)To determine the duration of ICU stay in days.  		 To assess the hemodynamic parameters( mean arterial pressure , heart rate ) post operatively at 30 minute, 1 hour, 3, 6, 12, 18, 24, 30, 36, 42, 48 hours after extubation. 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   30/07/2025 
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="0"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ranugandhi5747@gmail.com].

  6. For how long will this data be available start date provided 02-11-2026 and end date provided 24-07-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
One day before operation patient will be made to fill APAIS (Amsterdam preoperative anxiety and information scale) questionnaire for anxiety and total anxiety score will be noted .

Weight, fasting status, written informed consent and pac will be checked.
Routine vital monitors attached ( ECG, spo2 , EtCO2). Peripheral IV line, ijv Central line, arterial line for invasive BP monitoring secured and vitals (SBP, DBP, MAP, CVP) will be noted.
After preoxygenation with 100% oxygen, induction will be done with injection midazolam 0.05 mg/kg ,injection fentanyl 4 microgram/ kg, injection etomidate 0. 3 mg per kg and injection rocuronium 0.9 mg/kg

After surgery in cardiac ICU study participants put on ventilator and extubated as per standard criteria.

Intravenous paracetamol 1 g and injection tramadol 1 mg/ kg will be given 8 hourly.
When visual analog score exceed 4 , injection fentanyl 1 microgram per kg will be given.

Collection of data

Visual analogue score determined at 15 minutes after excavation and then 3 hr, 6, 12 ,18, 24, 30, 36, 42 ,48 hours postoperatively.
Total dose of fentanyl given within 48 hours after extubation .
Neurocognitive function by mini mental State examination ( MMSE) on post of day 1,2,3,4
Hemo dynamic parameter (mean arterial pressure ,heart rate) determined post operatively at 30 minute 1 hour 3 , 6 ,12, 18, 24 ,30, 36, 42, 48 hour
Duration of ICU stay in days.

Statistical analysis ( all data will be entered into a soft Excel spreadsheet and will be analyzed statistically using appropriate tests and software)
Conclusion
 
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