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CTRI Number  CTRI/2025/05/087140 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 16/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of intranasal dexmedetomidine and lignocaine spray on the laryngoscopy response during intubation. 
Scientific Title of Study   Comparison between intranasal dexmedetomidine and oropharyngeal lignocaine spray on attenuation of stress response during laryngoscopy for tracheal intubation in patients undergoing elective surgeries - A triple blinded randomized 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  Raichel Kurian 
Designation  Post graduate registrar in department of Anaesthesiology 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesiology Christian Medical College Vellore Tamil Nadu, India

Vellore
TAMIL NADU
632004
India 
Phone  8547726721  
Fax    
Email  kurian.raichel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Sajan Philip George 
Designation  Professor in department of Anaesthesiology 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesiology Christian Medical College Vellore Tamil Nadu India

Vellore
TAMIL NADU
632004
India 
Phone  0416 2282105  
Fax    
Email  sajanpg@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Raichel Kurian 
Designation  Post graduate registrar in department of Anaesthesiology 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesiology Christian Medical College Vellore Tamil Nadu, India


TAMIL NADU
632004
India 
Phone  8547726721  
Fax    
Email  kurian.raichel@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Fund , Institutional review board, Christian medical college Vellore district Tamil Nadu India pin 632004 
 
Primary Sponsor  
Name  Christian Medical College Fluid Research Fund 
Address  Office of Research Christian Medical College Vellore Tamil Nadu pin 632 002 
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 
Raichel Kurian  Christian Medical College Vellore  Department of Anaesthesiology Christian Medical College Vellore Tamil Nadu, India pin 632004
Vellore
TAMIL NADU 
8547726721

kurian.raichel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institutional Review Board christian medical college vellore  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  Dexmedetomidine   1 mcg per kg intranasal Dexmedetomidine using mucosal atomization device 30 minutes prior to induction of anaesthesia. 1microgram per kilogram dose of dexmedetomidine is given as a single dose 30 minutes prior to anaesthesia in the nose using a spraying device in the holding bay. Placebo with normal saline will be given for patients belonging to the lignocaine at this time with equivalent volume to dose of lignocaine which is 1.5miligram per kiligram 
Comparator Agent  Lignocaine  1.5mg per kg of 10 percent lignocaine spray using mucosal atomizer device in the oropharynx just prior to induction of anaesthesia. A single dose of 10% lignocaine spray is used and 1.5 milligram per kg dose is given in the mouth ie oropharynx just before starting induction of anaesthesia in operation theatre using atomizing device . Patients will receive normal saline as placebo just prior to induction if the belong to the dexmedetomidine group with equivalent volume of the dose which is 1 microgram per kilogram. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults of age 18 and 60 years of ASA I and II undergoing elective surgery under general anaesthesia with oral endotracheal tube intubation 
 
ExclusionCriteria 
Details  Patient refusal
Allergy to either dexmedetomidine or lignocaine
ASA III and IV
Anticipated difficult airway
Severe upper respiratory tract infection
Known cardiac disease or liver disease
BMI greater than 30kg per m2
Pregnant women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of intranasal dexmedetomidine and lignocaine spray on the laryngoscopy response in patients undergoing elective surgeries  baseline , 2 minute, 5 minutes, 10 minutes post tracheal intubation. Heart rate and Blood pressure will be measured 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of sore throat in patients post endotracheal intubation  more than 6 hours to less than 10 hours post surgery 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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 3 
Date of First Enrollment (India)   01/06/2025 
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 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  

Through this study we aim to compare the effect of preoperative intranasal dexmedetomidine and lignocaine spray in attenuation of haemodynamic responses to laryngoscopy for endotracheal intubation in patients undergoing elective surgeries. Patients planned for elective surgeries who are willing to participate and meets inclusion criteria will be enrolled for the study. An informed consent will be obtained from patients preoperatively using an information sheet. Participants of the study will be divided into two groups by computer generated block randomization. Group A will receive a 1mcg per kg of intranasal dexmedetomidine with atomizing device of company MAD Nasal Intranasal Mucosal Atomization Device 30 minutes prior to induction in holding bay. Group B will receive 1.5mg per kg of 10 percent lignocaine spray prior to induction onto the oropharyngeal mucosa with atomization device. Both groups will receive normal saline placebo at the respective time. All patients will have standard ASA monitoring with peripheral intravenous access. General anaesthesia will be administered as per standard institutional protocols. Induction will be done with propofol 1 to 2mg per kg, Fentanyl 1 to 2mcg per kg and titrated to effect to maintain haemodynamics, Atracurium 0.5mg per kg.  Anaesthesia will be maintained with a MAC of 0.7 to 0.8 of isoflurane. Unanticipated difficult airway, Intubation time, number of attempts, haemodynamic response to scopy  as Heart rate and Blood Pressure at baseline, 2 ,5 and 10 min post tracheal intubation to be noted. Any bradycardia, hypotension, tachycardia or hypertension greater than 20 percent will be treated as per standard guidelines. Incidence of sore throat post surgery will be documented.

 

 
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