| CTRI Number |
CTRI/2026/01/100347 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods of diagnosing early postoperative cognitive disorders in elderly patients undergoing surgery under anaesthesia. |
|
Scientific Title of Study
|
Comparison of two methods Mini mental state examination (MMSE) vs Montreal cognitive assessment (MoCA) in diagnosing early postoperative cognitive disorders in elderly patients undergoing elective surgery under general anaesthesia. |
| 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 ANJU GHAI |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical care, Pt. B.D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416974794 |
| Fax |
|
| Email |
dranjughai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANJU GHAI |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical care, Pt. B.D. Sharma PGIMS, Rohtak
HARYANA
124001
India |
| Phone |
9416974794 |
| Fax |
|
| Email |
dranjughai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MEDHA MEHLA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical care, Pt. B.D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8076901054 |
| Fax |
|
| Email |
medhamehla14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak, Haryana- 124001 |
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma PGIMS, Rohtak, Haryana- 124001 |
| Address |
Department of Anaesthesiology and Critical Care Pt. B.D. Sharma PGIMS, Rohtak, Haryana- 124001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ANJU GHAI |
Pt. B.D. Sharma PGIMS |
Department of Anaesthesiology and Critical Care Second floor, Modular OT Complex
Pt. B.D. Sharma PGIMS Rohtak, Haryana 124001
Rohtak
HARYANA |
9416974794
dranjughai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of Mini mental state examination vs Montreal cognitive assessment in diagnosing early postoperative cognitive disorders in elderly patients undergoing elective surgery under general anaesthesia |
The patients will be enrolled preoperatively. Patient aged more than 60 years undergoing elective non cardiac surgeries including gynaecological, urological, hepatobiliary, colorectal and orthopaedic procedures under general anaesthesia, will be administered MMSE and MOCA
concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively. Age, sex, education level, ASA grade, h/o cardiovascular disease and other comorbidities, type of surgery , site of surgery will be noted prior to administering the tests. Anaesthesia will be
standardised using intravenous glycopyrrolate 0.01 mg/kg , intravenous propofol 2mg/kg, fentanyl 2mcg/kg and atracurium 0.5 mg/kg . Anaesthesia induction will be followed by endotracheal
intubation or LMA insertion. Anaesthesia will be maintained according to the standard protocol of the department. Reversal will be carried out with combination of neostigmine(0.05 mg/kg) and
glycopyrrolate(0.01 mg/kg). Surgical time and intraoperative blood loss will be noted during surgery.
We will focus on assessing the patient within 48 hours of surgery as we are diagnosing early postoperative cognitive disorders.
|
| Comparator Agent |
Mini mental state examination |
The patients will be enrolled preoperatively. Patients aged more than 60 years undergoing elective non cardiac surgeries including gynaecological, urological, hepatobiliary, colorectal and orthopaedic procedures under general anaesthesia, will be administered MMSE concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively. Age, sex, education level, ASA grade, h/o cardiovascular disease and other comorbidities, type of surgery , site of surgery will be noted prior to administering the tests. Anaesthesia will be standardised using intravenous glycopyrrolate 0.01 mg/kg , intravenous propofol 2mg/kg, fentanyl 2mcg/kg and atracurium 0.5 mg/kg . Anaesthesia induction will be followed by endotracheal intubation or LMA insertion. Anaesthesia will be maintained according to the standard protocol of the department. Reversal will be carried out with combination of neostigmine(0.05 mg/kg) and glycopyrrolate(0.01 mg/kg). Surgical time and intraoperative blood loss will be noted during surgery.
We will focus on assessing the patient within 48 hours of surgery as we are diagnosing early postoperative cognitive disorders.
|
| Comparator Agent |
Montreal cognitive assessment |
The patients will be enrolled preoperatively. Patients 60 years undergoing elective non cardiac surgeries including gynaecological, urological, hepatobiliary, colorectal and orthopaedic procedures under general anaesthesia, will be administered MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively. Age, sex, education level, ASA grade, h/o cardiovascular disease and other comorbidities, type of surgery , site of surgery will be noted prior to administering the tests. Anaesthesia will be standardised using intravenous glycopyrrolate 0.01 mg/kg , intravenous propofol 2mg/kg, fentanyl 2mcg/kg and atracurium 0.5 mg/kg . Anaesthesia induction will be followed by endotracheal intubation or LMA insertion. Anaesthesia will be maintained according to the standard protocol of the department. Reversal will be carried out with combination of neostigmine(0.05 mg/kg) and glycopyrrolate(0.01 mg/kg). Surgical time and intraoperative blood loss will be noted during surgery. We will focus on assessing the patient within 48 hours of surgery as we are diagnosing early postoperative cognitive disorders. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more 60y scheduled for elective surgery under general anaesthesia will be recruited
preoperatively. |
|
| ExclusionCriteria |
| Details |
Patients who declined participation or were unsuitable for neurocognitive assessment, Previously diagnosed cognitive impairment, Severe visual/auditory impairments, Multiple procedures requiring anaesthesia scheduled during follow up, Illiterate patients or inability to comprehend. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare cognitive assessment results of elderly patients on MMSE and MoCA in order to
assess early postoperative cognitive disorder after undergoing elective surgery under general
anaesthesia. |
The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE and MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively. As our focus is on diagnosing early postoperative cognitive disorders so we will focus on assessing patients within 48 hours of surgery under anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictive accuracy of MMSE & MoCA scores in identifying patients at risk of developing POCD |
The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE & MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively.Data will be compiled, compared & appropriate
statistical test will be applied to analyse the results.We will focus on assessing the patient within 48 hours of surgery as we are diagnosing early postoperative cognitive disorders. |
| To assess the correlation among MMSE & MoCA in the perioperative setting for diagnosing cognitive impairment. |
The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE & MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively.Data will be compiled, compared & appropriate
statistical test will be applied to analyse the results.We will focus on assessing the patient within 48 hours of surgery as we are diagnosing early postoperative cognitive disorders. |
To identify which cognitive domains (e.g., memory, attention, executive function) show the
most significant decline postoperatively, & determine how well MMSE & MoCA capture
these domain-specific impairment.
|
The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE & MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively.Data will be compiled, compared & appropriate
statistical test will be applied to analyse the results.We will focus on assessing the patient within 48 hours of surgery as we are diagnosing early postoperative cognitive disorders. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/01/2026 |
| 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="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 - NO
|
|
Brief Summary
|
This study aims to comprehensively evaluate the Mini-Mental State Examination
(MMSE) and the Montreal Cognitive Assessment (MoCA) in assessing early postoperative cognitive
disorder in elderly patients undergoing elective surgery under general anaesthesia. Patients aged more than 60y scheduled for elective surgery
under general anaesthesia will be recruited
preoperatively. They will be administered MMSE and MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively.
Age, sex, education level, ASA grade, h/o cardiovascular disease and other comorbidities, type of
surgery , site of surgery will be noted prior to administering the tests. Anaesthesia will be
standardised using intravenous glycopyrrolate 0.01 mg/kg , intravenous propofol 2mg/kg, fentanyl
2mcg/kg and atracurium 0.5 mg/kg . Anaesthesia induction will be followed by endotracheal
intubation or LMA insertion. Anaesthesia will be maintained according to the standard protocol of the
department. Reversal will be carried out with combination of neostigmine(0.05 mg/kg) and
glycopyrrolate(0.01 mg/kg). Surgical time and intraoperative blood loss will be noted during surgery. ) Patients’ preoperative demographic information (sex, age, level of education), comorbidities,
preoperative cognitive status and site and type of surgery will be noted, intraoperative data comprising of anaesthesia technique, intraoperative blood loss, time of
surgery and any specific episodes of hypotension, blood transfusions, cardiac arrythmias will
be noted, Data on postoperative cognitive assessments and any complications will be collected
postoperatively |