| CTRI Number |
CTRI/2025/07/090969 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the comparison of two drugs with ultrasonic nebulisation for attenuating intubation response to laryngoscopy. |
|
Scientific Title of Study
|
Evaluation of dexmedetomidine nebulisation versus four percentage lignocaine nebulisation for attenuation of intubation response to laryngoscopy & endotracheal tube intubation: Prospective randomised controlled 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 Neredukomma Sricharan |
| Designation |
Junior resident (M.D) |
| Affiliation |
Nizams Institute of medical sciences |
| Address |
Department of Anaesthesiology and intensive care, Nizams institute
of medical sciences, punjagutta Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India
Hyderabad TELANGANA 500082 India |
| Phone |
7569376605 |
| Fax |
|
| Email |
doctorsricharan.2410@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srilata Moningi |
| Designation |
Professor |
| Affiliation |
Nizams Institute of medical sciences |
| Address |
Department of Anaesthesiology and intensive care, Nizams institute
of medical sciences, punjagutta Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India
Hyderabad TELANGANA 500082 India |
| Phone |
9848352882 |
| Fax |
|
| Email |
srilata_m1973@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Srilata Moningi |
| Designation |
Professor |
| Affiliation |
Nizams Institute of medical sciences |
| Address |
Department of Anaesthesiology and intensive care, Nizams institute
of medical sciences, punjagutta Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India
Hyderabad TELANGANA 500082 India |
| Phone |
9848352882 |
| Fax |
|
| Email |
srilata_m1973@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Nizams institute of medical sciences, panjagutta, Hyderabad, Telangana, 500082 |
|
|
Primary Sponsor
|
| Name |
Dr Neredukomma Sricharan |
| Address |
Junior resident (M.D.), Department of anaesthesiology and intensive
care,Nizams institute of medical sciences, punjagutta, Hyderabad,
500082, Telangana. Ph no.7569376603, doctorsricharan.2410@gmail.com |
| Type of Sponsor |
Other [ [Self]] |
|
|
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 Neredukomma Sricharan |
Nizams institute of medical sciences |
Department of
anaesthesiology and
intensive care, Nizams
institute of medical
sciences, panjagutta,
Hyderabad, Telangana,
500082
Hyderabad
TELANGANA Hyderabad TELANGANA |
7569376603
doctorsricharan.2410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nims institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: S669||Injury of unspecified muscle, fascia and tendon at wrist and hand level, (3) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (4) ICD-10 Condition: E078||Other specified disorders of thyroid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasonic nebulization with 4% lignocaine |
Before 30 minutes of intubation patient is nebulized with 4% lignocaine (0.075mcg/kg) and calculate the sedation score and note the vitals of baseline and at 1min,3min,5min,7min,10min. |
| Intervention |
Ultrasonic nebulization with dexmedetomidine |
Before 30 minutes of intubation patient is nebulized with dexmedetomidine (1mcg/kg) and calculate the sedation score and note the vitals of baseline and at 1min,3min,5min,7min,10min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients requiring general anesthesia and tracheal intubation.
2. ASA grade I and II patients.
3. Duration of surgery less than 4 hours.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal 2. Emergency surgeries 3. Hemodynamically unstable patients 4. Pregnancy 5.Previous allergy to anesthetic agents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy & safety of nebulized dexmedetomidine, nebulized 4% lignocaine for blunting of pressor effect caused by laryngoscopy and endotracheal intubation. |
At baseline, 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes , 10
minutes, after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the post-operative complications occurring after intubation and laryngoscopy like sore throat, difficulty in swallowing, speech problems and side effects of anesthetic agents. |
postoperative period within 24 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 |
|
Date of First Enrollment (India)
|
26/07/2025 |
| 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="0" Months="6" 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
|
Laryngoscopy and intubation trigger transient hemodynamic responses, including increased heart rate, blood pressure, and myocardial oxygen demand, due to somatovisceral reflexes. While generally well-tolerated in healthy patients, these changes can be harmful in individuals with cardiovascular or cerebrovascular conditions. To mitigate this response, various agents such as opioids, beta-blockers, calcium channel blockers, vasodilators, and lidocaine have been used via intravenous, topical, or nebulized routes. Nebulization is preferred due to its fewer side effects and effectiveness in attenuating airway irritation. Lidocaine, a local anesthetic, is widely used in nebulized form to blunt intubation-induced cardiovascular responses. Dexmedetomidine, an alpha-2 adrenoceptor agonist with sedative and sympatholytic properties, is also being explored for nebulized administration to avoid intravenous side effects like bradycardia and hypotension. Ultrasonic nebulization is a promising technique that produces fine aerosol particles for deeper airway penetration, requiring lower doses and reducing toxicity risks. While lidocaine nebulization is well-studied, few studies have assessed ultrasonic nebulization of dexmedetomidine. This study aims to compare the efficacy of ultrasonic nebulization of dexmedetomidine versus 4% lidocaine in attenuating the pressor response to laryngoscopy and intubation. |