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CTRI Number  CTRI/2024/11/076406 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 03/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of general anaesthesia and regional anaesthesia (like spinal and epidural) in terms of the possibility of producing problems in postoperative brain function among elderly patients.  
Scientific Title of Study   Comparison of incidence of postoperative cognitive dysfunction after general anaesthesia with regional anaesthesia among elderly postoperative patients 
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 Fathima Mohamed K 
Designation  Junior Resident 
Affiliation  K S Hegde Medical Academy 
Address  K S Hegde Medical Academy Dearalakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8086240710  
Fax    
Email  fathima.mohamed53@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sripada G Mehandale 
Designation  Professor and HOD Department of Anaesthesiology and Critical Care 
Affiliation  K S Hegde Medical Academy 
Address  K S Hegde Medical Academy Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448384310  
Fax    
Email  sripadamehandale@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Fathima Mohamed K 
Designation  Junior Resident 
Affiliation  K S Hegde Medical Academy 
Address  K S Hegde Medical Academy Deralakatte, Mnagalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8086240710  
Fax    
Email  fathima.mohamed53@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,K.S.HEGDE MEDICAL ACADEMY,DERALAKATTE ,MANGALORE 
 
Primary Sponsor  
Name  K S Hegde Medical Academy 
Address  K S Hegde Medical Academy Deralakatte, Mangalore Pin code- 575018 
Type of Sponsor  Research institution and hospital 
 
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 Sripada G Mehandale  K S Hegde Hospital Affiliated to K S Hegde Medical Academy  Nitte (Deemed to be university), Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA 		 9448384310

sripadamehandale@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITTEE, K S Hegde Medical Academy, NITTE (Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, (2) ICD-10 Condition: E049||Nontoxic goiter, unspecified, (3) ICD-10 Condition: N201||Calculus of ureter, (4) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (5) ICD-10 Condition: K37||Unspecified appendicitis, (6) ICD-10 Condition: H701||Chronic mastoiditis, (7) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (8) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (9) ICD-10 Condition: L039||Cellulitis and acute lymphangitis,unspecified, (10) ICD-10 Condition: N630||Unspecified lump in unspecified breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Patient’s age > 60 years
2 Either gender
3 ASA PS I, II, III
 
 
ExclusionCriteria 
Details  1 Patients who refuse to consent
2 Patients with preexisting cognitive disorders
3 Patients who are unable to perform HMSE questionnaire
4 Patients who are on psychiatric or sedative medications
5 Patients undergoing neurological/ cardiac surgeries
6 Patients with neurological disorders
7 Patients with acid base and electrolyte abnormalities
8 Alcoholic and drug abusers
9 Patients with history of similar surgery in the past
10 Surgeries longer than 4 hours
11 Surgeries done under combined GA and RA technique
12 Patients who are unable or not ready to take video call
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To measure the prevalence of cognitive dysfunction among elderly postoperative patients (by using HMSE) after GA and RA
2. To compare the incidence of POCD after GA and RA

 		 During pre-anaesthetic evaluation and within 24hours after surgery patients will assessed with CAM score and HMSE score and after 2 weeks and 4 weeks by HMSE score 
 
Secondary Outcome  
Outcome  TimePoints 
1.To find out time required for recovery from POCD among elderly patients
2. To find out whether all patients undergoing GA and RA recovered from POCD after 4 weeks of postoperative period 		 During pre-anaesthetic evaluation and within 24hours after surgery patients will assessed with CAM score and HMSE score and after 2 weeks and 4 weeks by HMSE score 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   20/11/2024 
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  

After getting approval for the study protocol by the Institutional Ethics Committee, a total number of 100 patients including men and women above the age of 60 years will be enrolled into the study. Informed written consent will be obtained from the patient. After a thorough preoperative evaluation, patients will be fasted for eight hours as per standard guidelines. Patients will be given Tab. Alprazolam (0.5 mg for <50 kg, 0.25 mg for >50 kg) at 10 pm on the preoperative night and 7 am on the operative day and Tab. Pantoprazole 40 mg at 10 pm on the preoperative day in case of elective procedures. Patients will be given Tab. Alprazolam (0.5 mg for <50 kg, 0.25 mg for >50 kg) and Tab. Pantoprazole 40 mg at least two hours before the surgery, as per the institutional practice.

 

They will receive either general anaesthesia or regional anaesthesia according to the surgical need. Patients receiving general anaesthesia will be under group G and those receiving regional anaesthesia will be under group S.

 

Patients will be given general anaesthesia and regional anaesthesia as per institutional protocol. Patient’s age, gender, BMI, surgical procedure, duration of surgery, ASA PS, educational status, incidence of intra-operative hypotension, history of transfusion of blood or blood products, intra-operative blood loss, ICU admission, any other intra-operative major events will also be noted.

 

HMSE (Hindi Mental State Examination) and CAM (Confusion Assessment Method) will be used to assess POCD, of which CAM and HMSE will be used once before surgery to assess the baseline cognitive status of patient and about 24 hours after surgery.  HMSE will be used after two weeks and four weeks. 2nd and 4th week cognitive assessment is done through video call. If the participants found have significant and persistent cognitive deficits at four weeks postoperative, the same will be informed to the surgeon who operated on the patient.

 

HMSE is translated and validated in local vernacular (Kannada and Malayalam) by the persons proficient in English and the respective language as the English translation is already available. Of the four domains tested in HMSE, there is a test for registration which requires drawing a shape on a piece of paper. Therefore, the video call has to be performed to complete the test and interpret.

 

 
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