| 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
|
|
|
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
|
|
|
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.
|