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CTRI Number  CTRI/2025/10/096403 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Administration of dexmedetomidine nebulisation prior will improve the intraoperative hemodynamic status of patients. 
Scientific Title of Study   Influence of dexmedetomidine nebulisation on isoflurane requirement in patients undergoing entropy guided general anaesthesia- a double blinded randomised 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 Sangamesh Nainegali 
Designation  Professor  
Affiliation  S.Nijalingappa medical college and HSK hospital,Bagalkot. 
Address  Department of Anaesthesiology, SNMC and HSK hospital, Navanagar,Bagalkot Karnataka 587102 India

Bagalkot
KARNATAKA
587102
India 
Phone  9845268463  
Fax    
Email  ndrsangamesh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangamesh Nainegali 
Designation  Professor  
Affiliation  S.Nijalingappa medical college and HSK hospital,Bagalkot. 
Address  Department of Anaesthesiology, SNMC and HSK hospital, Navanagar,Bagalkot Karnataka 587102 India

Bagalkot
KARNATAKA
587102
India 
Phone  9845268463  
Fax    
Email  ndrsangamesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKowsthuba Narayan 
Designation  Junior Resident  
Affiliation  S.Nijalingappa medical college and HSK hospital,Bagalkot. 
Address  Department of Anaesthesiology, SNMC and HSK hospital,Navanagar,Bagalkot Karnataka 587102 India

Bagalkot
KARNATAKA
587102
India 
Phone  9513353156  
Fax    
Email  kowsthubanarayan1908@gmail.com  
 
Source of Monetary or Material Support  
patients belonging to ASA1&2 coming to H S K hospital posted for elective surgeries under general anaesthesia  
 
Primary Sponsor  
Name  SNijalingappa medical college  
Address  Department of anaesthesia, second floor,SNMC and HSK hospital,Bagalkot,Karnataka 
Type of Sponsor  Private 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 Sangamesh Nainegali   HSK hospital, S nigalinappa medical college,Navanagar,Bagalkot   first floor, major OT complex, SNMC & HSK hospital,Navanagar,Bagalkot
Bagalkot
KARNATAKA 
9845268463

ndrsangamesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC-institutional ethics committee on human subjects research  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  nil  nil 
Comparator Agent  to compare the hemodynamics in group NS and group dexmedetomidine   nebulisation normal saline is given to group NS and nebulisation with dexmedetomidine is given to group dexmedetomidine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient scheduled for elective surgeries requiring general anaesthesia lasting for less than 2 hours.
patients belonging to ASA 1 & 2 
 
ExclusionCriteria 
Details  patients under going emergency surgeries .
Obese individuals (BMI more than 30).
patients with known allergy to dexmedetomidine.
patients belonging to ASA 3 & 4.
Patients with cardiovascular and respiratory disorders. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to decrease the consumption of isoflurane consumption in patients receiving dexmedetomidine nebulisation and improve the patient recovery  72hours 
 
Secondary Outcome  
Outcome  TimePoints 
to decrease the complications & to maintain the hemodynamic status   72 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/11/2025 
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="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 - NO
Brief Summary  
Inhalational anaesthetic agents like Isoflurane are commonly used to maintain depth of anaesthesia but they are associated with adverse effects such as hemodynamic instability, respiratory depression and potential occupational hazards due to operating room pollution .Minimising the dose of these agents while maintaining adequate depth of anaesthesia is essential for optimizing patient safety
Dexmedetomidine is a potent centrally acting highly sedative alpha 2 receptor agonist with sympatholytic, amnestic, analgesic, anxiolytic properties .
Nebulised dexmedetomidine offers a non-invasive, patient friendly alternative for premedication, which may help attenuate the intraoperative stress response and reduce the requirement of inhaled agent 
Entropy monitoring, derived from electroencephalographic signals, enables realtime titration of anaesthetic agents, ensuring precise control over anaesthetic depth. Integrating entropy guidance with dexmedetomidine nebulization may potentially lower isoflurane consumption, reduce sympathetic stimulation and minimize perioperative complications thereby improving the recovery profile of patients.Despite promising pharmacological profiles, there is limited literature on the combined use of nebulized dexmedetomidine and entropy guided anaesthesia.
This gap underscores the need for further investigation to validate its efficacy in reducing inhalational agent requirements, improving hemodynamic stability, and minimizing intraoperative hazards.Thus, this study aims to evaluate the efficacy of nebulized dexmedetomidine in reducing the requirement of inhalational anaesthetics using entropy-guided monitoring and recovery in terms of time required for eye opening and extubation.

 
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