| CTRI Number |
CTRI/2025/08/092739 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare blood pressure response to tracheal intubation in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
EVALUATION OF TWO DIFFERENT DOSES OF NEBULISED DEXMEDETOMIDINE ON ATTENUATING HEMODYNAMIC STRESS RESPONSE TO LARYNGOSCOPY AND INTUBATION IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA:A DOUBLE BLINDED RANDOMISED CONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anilkumar Ganeshnavar |
| Designation |
Professor |
| Affiliation |
S Nijalingappa Medical College |
| Address |
Department of Anaesthesiology
SNMC and HSK Hospital,Navanagar, Bagalkot-587102
Bagalkot KARNATAKA 587102 India |
| Phone |
9964526598 |
| Fax |
|
| Email |
anilganesh22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anilkumar Ganeshnavar |
| Designation |
Professor |
| Affiliation |
S Nijalingappa Medical College |
| Address |
Department of Anaesthesiology
SNMC and HSK Hospital,Navanagar, Bagalkot-587102
Bagalkot KARNATAKA 587102 India |
| Phone |
9964526598 |
| Fax |
|
| Email |
anilganesh22@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Soundarya G R |
| Designation |
Junior Resident |
| Affiliation |
S Nijalingappa Medical College |
| Address |
Department of Anaesthesiology
SNMC and HSK Hospital,Navanagar, Bagalkot-587102
Bagalkot KARNATAKA 587102 India |
| Phone |
6363295470 |
| Fax |
|
| Email |
soundaryagr22497@gmail.com |
|
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Source of Monetary or Material Support
|
| Patients coming to S N Medical college and HSK hospital posted for elective surgery under GA who wish to participate in trial voluntarily |
|
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Primary Sponsor
|
| Name |
S Nijalingappa medical college |
| Address |
Department of Anesthesiology,
SNMC and HSK Hospital,navanagar Bagalkot-587102 Karnataka |
| Type of Sponsor |
Private medical college |
|
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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 Anil kumar Ganeshnavar |
S Nijalingappa Medical College and hsk hospital |
Major OT complex 1st floor IPD Block Bagalkot KARNATAKA |
9964526598
anilganesh22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE BAGALKOT |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulisation |
The procedure will be performed 15 minutes before the anticipated intubation
Group A 1mcg/kg nebulized dexmedetomidine with 5ml normal saline
Group B 2mcg/kg nebulized dexmedetomidine with 5ml normal saline
|
| Comparator Agent |
To compare haemodynamic stress response between two doses |
1. To estimate and compare the hemodynamic parameters HR SBP MAP in between two doses of dexmedetomidine at various time interval
T1 after nebulization
T2 before tracheal intubation
T3 after tracheal intubation
T4 5minutes after tracheal intubation
T5 at the closure of the skin incision
T6 immediately after tracheal extubation
T7 5 minutes after tracheal extubation
2. To assess and compare the cough response at extubation and the incidence rate of postoperative sore throat between group A and group B. at 0 2nd 4th and 6th hour after extubation
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of ages 20 to 60 years
American Society of Anaesthesiologists grade I or II of both gender
Patients undergoing elective surgery requiring GA
|
|
| ExclusionCriteria |
| Details |
Patient with a history of sore throat or upper respiratory tract infection
Hemodynamically unstable patients
Emergency patients
Patents with a history of allergy to dexmedetomidine
5. Patients with a history of cardiac, liver, or renal disorders.
6. Patient with a difficult airway where the anticipated
duration of laryngoscopy exceeded 15 seconds
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To estimate and compare two different doses Group-A (1mcg/kg) and Group-B (2mcg/kg) of nebulized dexmedetomidine to attenuate haemodynamic stress response to laryngoscopy and intubation at different time interval during intubation |
THE PRIMARY OBJECTIVE PARAMETERS WILL BE MEASURED AT VARIOUS TIME POINT ARE
T0 baseline before the procedure of nebulization
T1 after nebulization
T2 before tracheal intubation
T3 after tracheal intubation
T4 5 minutes after tracheal intubation
T5 at the closure of skin incision
T6 immediately after tracheal extubation
T7 5 minutes after tracheal extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To estimate and compare the hemodynamic parameters in group A and group B at extubation.
2. To assess and compare the cough response at extubation and the incidence rate of postoperative sore throat between group A and group B.
|
6hours |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
25/08/2025 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The larynx is a richly innervated structure with abundant neurovascular supply. Laryngoscopy and tracheal intubation are generally associated with pressure on the larynx, which results in the activation of somatovisceral reflexes. Sympathoadrenal activation leads to the release of catecholamines, which results in a rise in hemodynamics. The duration of the intubation and the force exerted during the procedure directly affect the catecholamine response.It starts within 5–10 seconds, peaking at 1–2 minutes, and finally returning to its baseline readings in the next 5 minutes. Although this is a transient response with an average rise in systolic blood pressure (SBP) of 25–30 mmHg, and most healthy patients tolerate it without any untoward effect, it may prove to be extremely deleterious in patients with cerebrovascular or cardiovascular diseases. It has been associated with the precipitation of cardiac ischemia, cerebral stroke ,pulmonary edema. various preemptive measures are used to attenuate this response ,mainly addressed by intravenous or local agents. Most commonly employed alfa -2 agonist agonist ,opioids, beta blockers and local anesthetics .All of them are associated with various systemic side effects such as opioids with reduced respiratory drive, sedation, and postoperative nausea and vomiting and selective alfa 2 agonists such as dexmedetomidine with hypotension and bradycardia. Most of these are used preemptively but very few are administered through the nebulisation route. Direct instillation through nebulisation is new area with lesser systemic effects, which needs to be explored. Dexmedetomidine, an alpha 2 agonist, had been widely studied through the intravenous route where it has repeatedly proven itself to suppress the hemodynamic stress response, but systemic side effects such as hypotension and bradycardia are commonly associated, which may be troublesome. However, the recent literature has stated that the nebulization route has better bioavailability: nasal mucosa—65% and buccal mucosa—82%. Nebulised dexmeditomidine has been reported with a very short distribution half life (6minutes) and elimination half-life(2hours) withoit being associated with systemic side effects.It has reported in literature that dexmedetomidine when administered through the nebulisation route had reduced stress response to laryngoscopy and intubation also reported that nebulised dexmeditomidine can attenuate the postoperative sore throat in patients. |