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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  
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 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  
Status 
Not Applicable 
 
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.

 
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