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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  
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 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  
Status 
Not Applicable 
 
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.

 

 

 
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