| 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
|
|
|
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
|
|
|
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. |