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CTRI Number  CTRI/2026/01/102099 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Intranasal Dexmedetomidine vs Placebo for reducing heart rate and blood pressure during Tonsillectomy. 
Scientific Title of Study   Efficacy of Intranasal Dexmedetomidine in suppressing haemodynamic stress response to Boyle Davis Mouth Gag insertion in patients undergoing Tonsillectomy - A Randomised Double Blinded Placebo 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  Narra Pavithra 
Designation  Post Graduate  
Affiliation  Mahatma Gandhi Medical College and Research Institute , Pondicherry. 
Address  OT 14 , ENT OT , Department of Anaesthesiology , Mahatma Gandhi Medical College and Research Institute ,Pillayarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9100968555  
Fax    
Email  pavitranarra9999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gayatri Mishra 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute , Pondicherry. 
Address  OT 14, ENT OT , Department of Anaesthesiology ,Mahatma Gandhi Medical College and Research Institute ,Pillayarkuppam,Pondicherry.

Pondicherry
PONDICHERRY
607402
India 
Phone  9894354068  
Fax    
Email  drgayatrimishra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gayatri Mishra 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute , Pondicherry. 
Address  OT 14,ENT OT ,Department of Anaesthesiology ,Mahatma Gandhi Medical College and Research Institute ,Pillayarkuppam, Pondicherry.

Pondicherry
PONDICHERRY
607402
India 
Phone  9894354068  
Fax    
Email  drgayatrimishra@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute  
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry. Pillayarkuppam , Pondicherry 607402. 
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 
Dr Gayatri Mishra  Mahatma Gandhi Medical College Hospital  Department of Anaesthesiology,First floor,OT 14 ,Mahatma Gandhi Medical College and Research Institute,Pillayarkuppam Pondicherry 607402.
Pondicherry
PONDICHERRY 		 9894354068

drgayatrimishra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee (IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, (2) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine   The study involves administration of 1 mcg/kg Dexmedetomidine intranasally 30 mins before intubation in patients undergoing Tonsillectomy to reduce hemodynamic stress response during Boyle Davis Mouth Gag insertion. 
Comparator Agent  Intranasal saline   This study involves administration of intranasal saline as placebo in patients undergoing tonsillectomy  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Patients aged between 5-14 years of age of either sex posted for elective tonsillectomy 
 
ExclusionCriteria 
Details  1. Patients with contraindications to Dexmedetomidine
2. Patients with history of congenital heart diseases, heart blocks, hypertension,pre existing sinus bradycardia,obstructive sleep apnoea.
3. Patients care givers not giving the consent
 
 
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 
1.Heart rate
2.Blood pressure
3.Mean Arterial Pressure  		 1.Heart rate
2.Blood pressure
3.Mean Arterial Pressure
These study variables are measured at
Baseline
Before mouth gag insertion
Immediately after mouth gag insertion
Post mouth gag insertion 2 mins
Post mouth gag insertion 4 mins
Post mouth gag insertion 6 mins
Post mouth gag insertion 8 mins
Post mouth gag insertion 10 mins
Post mouth gag insertion 15 mins
Post mouth gag insertion 30 mins
Post mouth gag insertion 45 mins
Post mouth gag insertion 60 mins
During extubation
Post extubation 10 mins
 
 
Secondary Outcome  
Outcome  TimePoints 
Demographic details
Age, Weight, Height 		 Baseline 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 4 
Date of First Enrollment (India)   03/02/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (pavitra.narra9999@gmail.com).

  6. For how long will this data be available start date provided 07-10-2027 and end date provided 07-09-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The primary purpose of this study is to evaluate the effectiveness of intranasal dexmedetomidine administered preoperatively in attenuating hemodynamic stress response to  Boyle–Davis mouth gag application during tonsillectomy in paediatric patients (5–12 years) .This study hypothesize that intranasal dexmedetomidine, given as premedication, will  reduce hemodynamic stress response , compared with standard care during tonsillectomy. 
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