FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105402 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 03/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Dexmedetomidine in Preventing Memory and Thinking Problems in Elderly Patients After Non-Cardiac Surgery Under General Anaesthesia 
Scientific Title of Study   Role of dexmedetomidine in reducing neurocognitive dysfunction in elderly patients after non-cardiac 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 Mamta Jain 
Designation  professor 
Affiliation  Pt B.D. Sharma PGIMS,Rohtak,Haryana 
Address  Department of anaesthesiology and critical care,Pt B.D. Sharma, PGIMS, Rohtak Rohtak Haryana 124001 India

Rohtak
HARYANA
124001
India 
Phone  9958437432  
Fax    
Email  mamtajainsingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anusha R 
Designation  PG Resident 
Affiliation  Pt B.D. Sharma PGIMS,Rohtak,Haryana 
Address  Department of anaesthesiology and critical care,Pt B.D. Sharma, PGIMS, Rohtak Rohtak Haryana 124001 India

Rohtak
HARYANA
124001
India 
Phone  8553199679  
Fax    
Email  anushargowda827@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anusha R 
Designation  PG Resident 
Affiliation  Pt B.D. Sharma PGIMS,Rohtak,Haryana 
Address  Department of anaesthesiology and critical care,Pt B.D. Sharma, PGIMS, Rohtak Rohtak Haryana 124001 India

Rohtak
HARYANA
124001
India 
Phone  8553199679  
Fax    
Email  anushargowda827@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 
Address  Pt B.D. Sharma PGIMS Rohtak, Haryana,124001 
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 
Dr Anusha R  Pt B.D Sharma PGIMS Rohtak  Department of Anaesthesiology Modular OT complex Pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA 		 8553199679

anushargowda827@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research and ethics committee Pt.B.D Sharma PGIMS,Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infusion of dexmedetomidine before surgery  200 micrograms of dexmedetomidine diluted in 50ml NS resulting in 4mg per ml infusion. Intravenous infusion is started 15 minutes before surgery and Observed 
Comparator Agent  Infusion of normal saline before surgery  0.9% normal saline is filled in 50ml syringe and infusion is made and intravenous infusion will be started 15 minutes before surgery and observed 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  patients of either gender more than 60 years of age belonging to American society of anesthesiologist grade 1-2 ,undergoing surgery under general anesthesia will be included in the study 
 
ExclusionCriteria 
Details  Mini mental state examination score less than 24,a day before surgery, suffering from psychiatric illness or neurological cases, history pf psychotropic drug intake or drug abuse, uncontrolled underlying systemic disease, refusal to consent, surgeries lasting less than 1 hour or more than 3 hour, neurosurgeries, major hemodynamic instability or blood loss during surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients having early post operative cognitive dysfunction  Mini mental state examination score will be assessed
1 day prior to surgery,
6 hours after post operative period
24 hours after post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
To measure post operative pain using visual analog scale, post operative sedation using ramsay sedation score,perioperative haemodynamic parameters using HR,NIBP,SPO2 & adverse effects are measured  Outcome will be measured using visual analog scale,ramsay sedation score,HHR,NIBP, & SPO2
During PACU admission
1 hour after surgery
6 hours after surgery
24 hours after surgery 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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 4 
Date of First Enrollment (India)   17/03/2026 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 27-02-2026 and end date provided 27-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This prospective, randomised double blinded study evaluate the effect of intraoperative dexmedetomidine infusion on early postoperative cognitive dysfunction in elderly patients undergoing non-cardiac surgery under general anaesthesia. Patients aged more than 60 years with American society of anaesthesiologist grade 1-2 will be randomly allocated to receive either dexmedetomidine  or normal saline infusion. Cognitive function will be assessed using mini mental state examination scoreat 6 hours and 24 hours postoperatively compared to baseline secondary outcome include postoperative pain, postoperative sedation, intraoperative haemodynamic parameters such as heart rate, BP, saturation and adverse events. 
Close