| CTRI Number |
CTRI/2025/10/095648 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Assess the Effectiveness of Preoperative Nebulized Dexmedetomidine in Reducing Postoperative Confusion in Older Adults Undergoing General Anesthesia |
|
Scientific Title of Study
|
Evaluation Of Preoperative Nebulized Dexmedetomidine for the prevention of postoperative delirium in elderly patients undergoing surgery under general anesthesia - A Randomized Control Trial |
| 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 Geetha Muniraju |
| Designation |
Senior Consultant, Department of Anesthesia |
| Affiliation |
Fortis Hospital Limited |
| Address |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore Bangalore KARNATAKA 560076 India |
| Phone |
8971099794 |
| Fax |
|
| Email |
drgeethachetan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Geetha Muniraju |
| Designation |
Senior Consultant, Department of Anesthesia |
| Affiliation |
Fortis Hospital Limited |
| Address |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore Bangalore KARNATAKA 560076 India |
| Phone |
8971099794 |
| Fax |
|
| Email |
drgeethachetan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Geetha Muniraju |
| Designation |
Senior Consultant, Department of Anesthesia |
| Affiliation |
Fortis Hospital Limited |
| Address |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore Bangalore KARNATAKA 560076 India |
| Phone |
8971099794 |
| Fax |
|
| Email |
drgeethachetan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore 560076 |
|
|
Primary Sponsor
|
| Name |
Academic Investigator Initiated study |
| Address |
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore 560076 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Geetha Muniraju |
Fortis Hospital Limited |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore Bangalore KARNATAKA |
8971099794
drgeethachetan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FORTIS HOSPITAL 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 |
| Intervention |
Dexmedetomidine Nebulization |
Nebulized Dexmedetomidine at a dose of 1 mcg/kg body weight, diluted in 4 ml normal saline, administered once over 10 minutes in the preoperative area, approximately 10 minutes prior to induction of anesthesia |
| Comparator Agent |
Saline Nebulization |
Nebulized with 4ml saline administered once over 10 minutes in the preoperative area approximately 10 minutes prior to induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients consent to participate in the study.
2.Elderly patients of age more than 60 years.
3.Patients belonging to ASA 1,2, 3
4.Patients scheduled for elective surgeries under General Anesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Allergic to dexmedetomidine.
2. Heart block greater than first degree, Preexisting bradycardia with Heart rate less than 50.
3.History of Cognitive impairment like dementia, delirium, major stroke.
4.Use of anti-psychotics, antidepressants
5.Kidney or liver disease.
6.Body mass index more than 35 Kilogram per square Meter.
7.Intracranial surgeries.
8.Emergency surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of preoperative dexmedetomidine nebulization in reducing the incidence of postoperative delirium |
At the end of study duration data will be collected study duration 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the hemodynamical stability including incidence of adverse events such as hypotension and bradycardia |
At the end of study duration data will be collected study duration 12 months |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/10/2025 |
| 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="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
|
Post
operative mental and behavioral abnormalities are generally divided into three
situations: Emergence delirium, Post operative delirium and post operative
cognitive dysfunction (1). Postoperative
delirium (POD) is a common and significant complication, characterized by acute
disturbances in attention, awareness, and cognition, typically occurring
between postoperative days 1 and 5.
(2). Surgical trauma, anesthesia, pain, disturbances in sleep patterns,
changes in nutrition and delirium-inducing drugs such as high-dose narcotics,
benzodiazepines and anticholinergics further contribute to the development of
neurocognitive insults particularly in high-risk patients. Patients over 60 years old and those
with preexisting conditions such as dementia, cardiovascular disease, diabetes
and anemia are particularly vulnerable. POD can prolong recovery times, delayed discharge from the ICU and increase
hospital stays overall affecting functional independence & quality of life.
So, effective prevention of post operative delirium not only enhances patient
safety and recovery but also reduces health care costs.
The pathophysiology of
postoperative delirium (POD) is believed to be multifactorial, involving
neuroinflammation, systemic stress responses, and micro emboli or watershed strokes.
(4). Dexmedetomidine exerts its neuroprotective effects through multiple
mechanisms primarily via selective alpha2-adrenergic receptor agonism, by
reducing norepinephrine release. This leads to its both analgesic and sedative
properties. It also reduces the release of substance P and mitigates
nociceptive signaling. Dexmedetomidine interacts with imidazoline type 2 (I2)
receptors potentially regulating calcium levels and mitigating endoplasmic reticulum
stress-induced apoptosis which may protect against neuronal damage. It
modulates neurotransmitter pathways and studies show that patients treated
with dexmedetomidine has limited decrease in acetylcholinesterase (Ache) and
butyrylcholinesterase (B.Ch.E.) activity. This limits inflammation and the
systemic stress response to surgical trauma. (5)
Several drugs, including
melatonin, ramelteon, acetaminophen, neostigmine and corticosteroids, are being
studied for preventing postoperative delirium, but dexmedetomidine has the
strongest evidence supporting its effectiveness in prevention of POD. (6)
However,
there is limited research on the use of nebulized dexmedetomidine for
preventing post operative delirium in adults. Therefore, this study aims to
assess the efficacy of preoperative dexmedetomidine nebulization in preventing
post operative delirium in elderly patients undergoing surgeries under general anesthesia.
|