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.
- Registration Number
- CTRI/2024/11/076406
- Lead Sponsor
- K S Hegde Medical Academy
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 88
1Patient’s age > 60 years 2 Either gender 3ASA PS I, II, III.
1Patients who refuse to consent 2Patients with preexisting cognitive disorders 3Patients who are unable to perform HMSE questionnaire 4Patients who are on psychiatric or sedative medications 5Patients undergoing neurological/ cardiac surgeries 6Patients with neurological disorders 7Patients with acid base and electrolyte abnormalities 8Alcoholic and drug abusers 9Patients with history of similar surgery in the past 10Surgeries longer than 4 hours 11Surgeries done under combined GA and RA technique 12Patients who are unable or not ready to take video call.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To measure the prevalence of cognitive dysfunction among elderly postoperative patients (by using HMSE) 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 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
K S Hegde Hospital Affiliated to K S Hegde Medical Academy
🇮🇳Kannada, KARNATAKA, India
K S Hegde Hospital Affiliated to K S Hegde Medical Academy🇮🇳Kannada, KARNATAKA, IndiaDr Sripada G MehandalePrincipal investigator9448384310sripadamehandale@nitte.edu.in