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CTRI Number  CTRI/2025/11/097151 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 18/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of Epidural and Spinal Anaesthesia On Memory and Thinking Function in Elderly Patients Undergoing Lower Limb Surgery 
Scientific Title of Study   A Comperative study of Epidural vs Subarachnoid Block on Post Operative Cognitive Dysfunction on Elderly Frail Patients Posted For Lower Limb Orthopaedic 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  Ankita Rastogi 
Designation  Junior Resident 
Affiliation  Uttar Pradesh Institute Of Medical Sciences 
Address  Rani Laxmi bai hostel room no 106 Saifai Etawah.

Etawah
UTTAR PRADESH
206130
India 
Phone  08840991194  
Fax    
Email  ankirastogi291099@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Vikram Singh Rathore 
Designation  Associate Professor 
Affiliation  Uttar Pradesh Institute Of Medical Sciences 
Address  OPD Old building 3rd floor Department Of Anesthesiology UPUMS Saifai.

Etawah
UTTAR PRADESH
206130
India 
Phone  8826719977  
Fax    
Email  vikram2012.mmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ankita Rastogi 
Designation  Junior Resident 
Affiliation  Uttar Pradesh Institute Of Medical Sciences 
Address  Rani Laxmi bai hostel room no 106 Saifai Etawah.

Etawah
UTTAR PRADESH
206130
India 
Phone  08840991194  
Fax    
Email  ankirastogi291099@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University Of Medical Sciences Saifai Etawah(Dt),Uttar Pradesh(state).Pin-206130 
 
Primary Sponsor  
Name  Uttar Pradesh University Of Medical Sciences  
Address  Saifai, Etawah,Uttar Pradesh(state).Pin-206130 
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 
DrAnkita Rastogi  Uttarpradesh University of Medical sciences  Department of anaesthesiology , Saifai,etawah
Etawah
UTTAR PRADESH 		 8840991194

ankirastogi291099@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,saifai,UP,206130,UttarPradesh University of Medical Sciences.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F078||Other personality and behavioral disorders due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Epidural  the epidural block was performed at level of L3-L4 OR L4-L5 through a midline approach in a sitting position using 18G Tuohy needle and the loss of resistance technique the epidural space was identified. An epidural catheter was then inserted and secured.  
Intervention  Nil  Nil 
Intervention  Spinal  The subarachnoid block was performed at level of L3-L4 or L4-L5 through a midline approach in a sitting position using a 26G Quincke spinal needle. 12.5-15mg 0.5% hyperbaric Bupivacaine with adequate level of anaesthesia. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Patients scheduled for elective lower limb surgery.
2.Consent to participate.
3.Surgery time upto 2 hrs.
4.Patients having fraility score 5 or above.
5.ASA 2 and 3 
 
ExclusionCriteria 
Details  1.Patients refusal.
2. Patient having dementia, Mini-Mental status examination score less than 24 clinical, dementia scale more than 1 before the surgery.
3. Communication difficulties such as blindness and deafness
4. Psychiatric illnesses or taking psychotropic drugs
5. History of alcohol and drug abuse
6. Being unable to complete questionnaires.
7. Contraindication to neuraxial anaesthesia.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare postoperative cognitive function between Epidural and Subarachnoid block groups.  30 minutes before Surgery,30 minutes after Surgery,24hours after surgery,36 Hours after surgery,72 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the influence of frailty on the development of Post operative cognitive dysfunction.
To compare intraoperative haemodynamic stability between groups. 		 30 minutes before Surgery,30 minutes after Surgery,24hours after surgery,36 Hours after surgery,72 hours after surgery. 
 
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)   21/11/2025 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ankirastogi291099@gmail.com].

  6. For how long will this data be available start date provided 05-05-2027 and end date provided 05-05-2075?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Total 60 patients will be assigned randomly into one of the two groups of
30 each as follows: Group S-Patients who underwent spinal anasthesia and Group E-
Patients who underwent epidural anasthesia.
In both the groups, post-operative cognitive function assessment will be done to assess
cognitive function in both groups. Secondary outcomes like frailty assessment parameters,
hemodynamic changes,to assess correlation between frailty and cognitive function.

The cognitive function will be assessed 30min preoperatively and 30 min after surgery, and then after,24hrs and 48hrs,72hrs, after surgery using pre-validated, the Hindi Version of Mini Mental State Examination (MMSE) in 10 dimensions with a total score of 30. Preoperative and postoperative pain is assessed by numerical scale rating, postoperative pain managed, based on NRS scale less than 3, for group S pain is managed with inj. Paracetamol 15mg/kg iv 8hourly and inj. Diclofenac 1.5mg/kg im 12hrly.For group E 0.125% inj. Bupivacaine 10ml is given over 15minutes for NRS Scale less than 3.

 
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