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CTRI Number  CTRI/2021/09/036747 [Registered on: 22/09/2021] Trial Registered Prospectively
Last Modified On: 21/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A CLINICAL TRIAL TO STUDY COMPARISION OF 1 VS 2µg/kg OF DEXMEDETOMIDINE NEBULISATION PRE-OPERATIVELY FOR BLUNTING HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND INTUBATION 
Scientific Title of Study   ROLE OF PRE-OPERATIVE DEXMEDETOMIDINE NEBULISATION 1 VS 2µg/kg IN BLUNTING HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND INTUBATION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suneet Kathuria 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital, Ludhiana. 141001 Punjab India 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB
141001
India 
Phone  9814007622  
Fax  0161-2302620  
Email  suneetkathuria@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashima Mahajan 
Designation  PG Registrar Anaesthesia 
Affiliation  Dayanand Medical College and Hospital, Ludhiana. 141001 Punjab India 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB
141001
India 
Phone  7009656967  
Fax  0161-2302620  
Email  ashima.mahajan.71@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashima Mahajan 
Designation  PG Registrar Anaesthesia 
Affiliation  Dayanand Medical College and Hospital, Ludhiana. 141001 Punjab India 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB
141001
India 
Phone  7009656967  
Fax  0161-2302620  
Email  ashima.mahajan.71@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital, Tagore nagar, Civil Lines, Ludhiana. 141001 Punjab India 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Tagore nagar, Civil Lines, Ludhiana. 141001 Punjab India 
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 Suneet Kathuria  Dayanand Medical College and Hospital, Ludhiana.   Department of Anaesthesia Dayanand Medical College and Hospital Tagore Nagar, Civil Lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB 		 9814007622
0161-2302620
suneetkathuria@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee, Dayanand Medical College & Hospital, Ludhiana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V00-Y99||External causes of morbidity, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group: Pre-operative nebulisation with 0.9% NaCl  Patients will be nebulised for 10 minutes with 5 ml of solution containing 0.9% NaCl, 10 minutes before induction. 
Intervention  Pre-operative nebulisation with 2µg/kg of dexmedetomidine  Patients will be nebulised for 10 minutes with 5 ml of solution containing 2µg/kg of dexmedetomidine in 0.9% NaCl, 10 minutes before induction. 
Intervention  Pre-operative nebulisation with 1µg/kg of dexmedetomidine  Patients will be nebulised for 10 minutes with 5 ml of solution containing 1µg/kg of dexmedetomidine in 0.9% NaCl, 10 minutes before induction. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  • Age more than 18 years
• ASA I & II patients undergoing surgery under general anaesthesia
• Patient with Mallampati class 1 or 2
 
 
ExclusionCriteria 
Details  • Pregnant females
• Patient with unstable haemodynamics
• Predicted airway difficulty
• ASA III & IV patients
• Known allergy to dexmedetomidine
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• To find most effective dose of nebulised dexmedetomidine with minimal side effect in blunting haemodynamic response to laryngoscopy and intubation by comparing HR, SBP, DBP and MAP at pre-induction, pre-intubation, after-intubation and upto 10 minutes post intubation.   BASELINE, after 5 mins i.e during nebulisation, after 10 mins i.e post nebulusiation, Pre-induction, Pre-intubation, Post intubation and then after every one min till BP and HR comes normal. 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare effect of 1 & 2 μg/kg nebulised dexmedetomidine on reduction of induction dose of propofol.
• To compare incidence and magnitude of complication associated with use of 1 & 2 μg/kg nebulised dexmedetomidine.
 		 -During induction.
-Complication noticed throughout study 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
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   N/A 
Date of First Enrollment (India)   29/09/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet Published 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 - Data are available indefinitely at (Link to be included ashima.mahajan.71@gmail.com).

  6. For how long will this data be available start date provided 24-09-2022 and end date provided 30-06-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Dexmedetomidine, a potent, highly selective alpha-2 adrenergic receptor agonist have been used for blunting haemodynamic response to laryngoscopy and intubation through IV, intranasal and nebulised routes. Nebulised dexmedetomidine 1µg/kg effectively blunts increase in heart rate (HR) but not systolic blood pressure (SBP). Dexmedetomidine nebulisation with 2µg/kg dose may help in blunting both tachycardia and hypertensive response.A prospective, randomized, study will be conducted on 150 ASA I and II patients undergoing surgery under general anaesthesia with endotracheal tube (ETT) insertion, who will be divided into 3 groups of 50 patients each. In groups 0, I and II, patients will be nebulised for 10 minutes with 5 ml of 0.9% NaCl solution containing 0, 1 and 2 µg/kg  dexmedetomidine respectively, 10 minutes before induction. Heart rate, Systolic, diastolic and mean arterial pressure (MAP) will be monitored and recorded at regular intervals and the data so collected will be analysed statistically.

 
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