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CTRI Number  CTRI/2024/09/074002 [Registered on: 18/09/2024] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Anaesthesia Drugs (Dexmedetomidine And Ketamine )On Delirium  
Scientific Title of Study   A Prospective Study To Compare The Effect OF Intraoperative Sedation With Dexmedetomidine Versus Ketamine On Postoperative Delirium And Expression Of Inflammatory Markers In Elderly Patients Undergoing Hip Surgeries 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vignesh A S 
Designation  Pg Student 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anesthesia , Lady Hardinge Medical College , Shahid Bhagat Singh Marg

Central
DELHI
110001
India 
Phone    
Fax    
Email  vignesh.a.s123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Garima Agrawal 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anesthesia , Lady Hardinge Medical College , Shahid Bhagat Singh Marg

Central
DELHI
110001
India 
Phone  7200154160  
Fax    
Email  garima23369@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vignesh A S 
Designation  Pg Student 
Affiliation  Lady Hardinge Medical College 
Address  Department of Anesthesia , Lady Hardinge Medical College , Shahid Bhagat Singh Marg

Central
DELHI
110001
India 
Phone  7904221658  
Fax    
Email  vignesh.a.s123@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia , lady Hardinge medical college , Shahid Bhagat Singh Marg , Connaught Place , New Delhi , India 110001 
 
Primary Sponsor  
Name  lady hardinge medical college 
Address  Department of Anesthesia , lady Hardinge medical college , Shahid Bhagat Singh Marg , Connaught Place , New Delhi , India 110001 
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 Vignesh A S  Lady Hardinge Medical College and associated hospitals  Department of anaesthesia, academic building , 4th floor, room no.4232 lady hardinge medical college and associated hospital Central DELHI
Central
DELHI 
7904221658

vignesh.a.s123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lady Hardinge Medical College and associated Hospitals New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F05||Delirium due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  compare the sedation with dexmedetomidine I.v (loading dose of 0.5 µg/kg and maintenance dose 0.2-0.4 µg/kg/h) on post op delirium.sedation will be started post induction and discontinued on initiation of cutaneous suturing. total duration of intervention - during the intraoperative period. 
Comparator Agent  ketamine  compare the sedation with ketamine I.V (loading dose of 0.3mg/kg and a maintenance dose of 0.2- 0.3 mg/kg on post op delirium. sedation will be started post induction and discontinued on initiation of cutaneous suturingotal duration of intervention - during the intraoperative period. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients undergoing lower limb surgery under central neuraxial blockade; age more than 60 years; ASA physical status grade I- III 
 
ExclusionCriteria 
Details  Patients with a history of psychosis or long-term psychotropic medication use/ benzodiazepine use/chronic analgesic drugs, or history of alcohol/nicotine abuse.
Patients with evidence of severe infection (Total leucocyte count more than 14000 cells/cu.mm).
Patients with communication barrier (severe audiovisual impairment or inability to speak or inability to understand Hindi or English language).
Baseline Mini-Mental State Examination (MMSE) score of less than or equal to 23 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients developing postoperative delirium as assessed by DSM -5 criteria in both the groups i.e., group D and group K   baseline and at postoperative day 2  
 
Secondary Outcome  
Outcome  TimePoints 
Change in levels of IL-6 in pg/ml and CRP in mg/ml from preoperative period to postoperative day 2 (T2) in both the groups.
Proportion of patients developing intraoperative side effects such as bradycardia, tachycardia, hypertension, hypotension and desaturation in both the groups.
Correlation between occurrence of postoperative delirium and the expression of inflammatory markers. 
post op day 2 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2024 
Date of Study Completion (India) 01/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Delirium is a common postoperative complication that occurs in 5 to 52% of older adult patients after noncardiac surgery.Delirium is characterized by disturbance in attention, awareness, and cognition that develops acutely and fluctuates frequently throughout the course of the condition..Various pharmacological modalities like typical and atypical antipsychotics, alpha 2 agonists like dexmedetomidine and non-pharmacological techniques like early mobilization, adequate nutrition and sleep hygiene have been employed for the prevention of delirium.

Dexmedetomidine (DEX) is a highly selective α2-receptor agonist that provides sedation, analgesia, and anxiety relief. As an α2-adrenergic receptor agonist, Dexmedetomidine can also reduce the systemic inflammatory response and regulate the immune system by inhibiting the central sympathetic nervous system. Ketamine is a non-competitive NMDA receptor antagonist and also possess neuroprotective and antidepressant property.It has been reported in systematic reviews that intraoperative ketamine administration reduces postoperative markers of inflammation as well as postoperative pain and opioid consumption.Furthermore, delirium and depression in elderly people appear to be overlapping syndromes caused by similar pathophysiological mechanisms.In addition to these theoretical benefits, ketamine is inexpensive and there is extensive experience among anaesthetists internationally.Therefore, dexmedetomidine and ketamine can play a role in reducing the incidence of postoperative delirium in elderly patients undergoing hip surgeries alongside with the levels of pro inflammatory markers

 

 
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