| CTRI Number |
CTRI/2025/12/098777 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which Anesthesia Sedation Helps the Brain Recover Faster? Propofol or Dexmedetomidine |
|
Scientific Title of Study
|
Comparison of cognitive recovery using propofol or dexmedetomidine infusion on patients undergoing elective surgery under general anesthesia |
| 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 Geetanjali Pushkrana |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main Operation Theatre, Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001
Amritsar
PUNJAB
143001
India |
| Phone |
09872981079 |
| Fax |
|
| Email |
gitzgitz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiteshwar Walia |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main Operation Theatre, Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001
Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9878339933 |
| Fax |
|
| Email |
chiteshwarwalia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaina Kaur Shahi |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main Operation Theatre, Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001
Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
6239217208 |
| Fax |
|
| Email |
shahishaina21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
Sri Guru Ram Das Institute of Medical Sciences and Research |
Main OT, Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001
Amritsar
PUNJAB |
09814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
| Comparator Agent |
Dexmedetomidine infusion |
Group A: Dexmedetomidine infusion at a titrated dose ranging from 0.3 to 0.7 mcg/kg/hr, adjusted to maintain the Bispectral Index (BIS) between 40 and 60 to ensure adequate anaesthesia depth. |
| Intervention |
General Anaesthesia |
Induction of anaesthesia will be performed using etomidate at a dose of 0.2 to 0.5 mg/kg administered intravenously. duration of anaesthesia is induction to extubation. |
| Comparator Agent |
Propofol infusion |
Group B: Propofol infusion at a titrated dose of 100 to 200 mcg/kg/min, similarly adjusted to keep BIS values between 40 and 60. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Physical Status I or II.
2. Elective non-neurological, non-cardiac surgeries lasting 1–3 hours.
3.Preoperative MoCA scores within normal limits.
4.Patients able to read, write, and understand the vernacular language Punjabi or English.
5.Patients having primary level education. |
|
| ExclusionCriteria |
| Details |
1.Pre-existing cognitive dysfunction (MoCA less than 26).
2.Patient on Beta blockers
3.Low heart rate
4.History of neurological or psychiatric illness.
5.Chronic alcohol or drug abuse.
6.Hearing or visual impairments affecting test performance
7.Emergency surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare change in cognitive score |
To compare change in baseline cognitive score at 2, 6 and 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Adverse effects of drugs
2.Hemodynamic parameters: heart rate, systolic/diastolic BP. |
Continuous intraoperative, vitals such as heart rate, blood pressure, SpO2, respiratory rate will be recorded every 2min interval for first 10 min & then at 5 min interval till the end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/12/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Introduction: Postoperative cognitive dysfunction (POCD) is a common complication following general anaesthesia, impacting patient’s cognitive recovery. Propofol and Dexmedetomidine are widely used anaesthetic agents with differing pharmacological profiles that may influence cognitive outcomes differently. Aims and Objectives: To compare cognitive recovery in patients receiving dexmedetomidine versus propofol infusion during elective surgery under general anaesthesia. Methodology: This prospective, randomized, double-blinded study will include 60 ASA I-II patients aged more than 65yr undergoing elective non-neurological, non-cardiac surgery. Patients will be randomized to receive either dexmedetomidine (0.3–0.7 mcg per kg per hour) or propofol (100–200 mcg per kg per min) infusion for maintenance of anaesthesia. These will be used as adjuvants to General anaesthesia. The depth of anaesthesia will be monitored via BIS to maintain values between 40 and 60. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) at baseline and 6, 24 and 48hours postoperatively. Hemodynamic parameters and adverse effects such as bradycardia and hypotension will be recorded. Outcome/Significance: This study is significant as it aims to provide clear evidence comparing the effects of dexmedetomidine and propofol on cognitive recovery after elective surgery, addressing gaps in regional data. Its findings can guide anaesthetic choices to enhance patient safety, optimize postoperative cognitive function, and reduce anaesthesia-related complications. |