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CTRI Number  CTRI/2025/12/099074 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 13/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of nebulisation with the sedative drug dexmedetomidine on heart rate and blood pressure changes during laryngoscopy and tracheal intubation with breathing tube in patients undergoing surgery under general anaesthesia 
Scientific Title of Study   A randomised clinical trial on the effect of nebulised dexmedetomidine on hemodynamic response to laryngoscopy and intubation in patients undergoing surgery under general anesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M KONOM PHOM 
Designation  Post graduate trainee 
Affiliation  Regional Institute of Medical Sciences Imphal West Manipur India 
Address  Regional Institute of Medical Sciences Imphal West Manipur India

Imphal West
MANIPUR
795004
India 
Phone  9863734637  
Fax    
Email  konomphom98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  N Ratan Singh 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences Imphal West Manipur India 
Address  Regional Institute of Medical Sciences Imphal West Manipur India

Imphal West
MANIPUR
795004
India 
Phone  9436027270  
Fax    
Email  nratansingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  N Ratan Singh 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences Imphal West Manipur India 
Address  Regional Institute of Medical Sciences Imphal West Manipur India

Imphal West
MANIPUR
795004
India 
Phone  9436027270  
Fax    
Email  nratansingh@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal West Manipur India 795004 
 
Primary Sponsor  
Name  M Konom Phom 
Address  Regional Institute of Medical Sciences Imphal West Manipur India Pin code 795004 
Type of Sponsor  Other [Post graduate trainee] 
 
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 M Konom Phom  Regional Institute of Medical Sciences Imphal Manipur  All operation theatres of Regional Institute of Medical Sciences Imphal West Manipur India
Imphal West
MANIPUR 
9863734637

konomphom98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board Regional Institute of Medical Sciences Imphal Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine hydrochloride injection  Consenting participants will receive nebulization with 0.5mcg per kg of dexmedetomidine diluted with normal saline to a volume of 5 ml till all the drug is aerosolized thirty minutes before induction of general anaesthesia and hemodynamic parameters like heart rate and BP will be measured at different time points up to ten minutes after endotracheal intubation 
Comparator Agent  Normal saline 0.9 percent  Consenting patients will be randomly allocated into two groups. Study participants will receive nebulization with 5ml of normal saline thirty minutes before induction of general anaesthesia and hemodynamic parameters like heart rate and BP will be measured at different time points up to ten minutes after endotracheal intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of age group 18 to 60 years of either gender
2.Patients of American Society of Anaesthesiologists physical grade I or II 
 
ExclusionCriteria 
Details  1.Patients on medications that affect heart rate
2.Patients with uncontrolled hypertension or hypotension
3.Obese patients with BMI more than 30 kg per metre square
4.Allergy to study drug
5.Emergency surgeries or anticipated difficult airway
6.Patients with renal failure or known cardiovascular or neurosurgical pathology
7.Pregnant or lactating patients
History of recent upper respiratory tract infection 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemodynamic parameters (Heart rate, systolic and diastolic blood pressure and mean arterial pressure)  Baseline, during intubation, one minute, three minutes, five minutes, seven minutes and ten minutes after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   24/12/2025 
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="0"
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 - 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 - 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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Access will be restricted to the investigator and the supervisor, and the REB members on demand. The findings of the study based on the collective data will be published without identifying the individual.

  6. For how long will this data be available start date provided 12-12-2027 and end date provided 12-12-2036?
    Response - Immediately following publication. No end date.

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

The study will be conducted on, “The effect of nebulised Dexmedetomidine on hemodynamic response to laryngoscopy and intubation in patients undergoing surgery under general anaesthesia. A Randomised Clinical Trial. Here in our study, patients will be randomly allocated into two groups using a computer-generated block randomization sequence. A total of 52 ASA grade 1 or 2 patients, aged 18–60 years, of either gender, will be randomly allocated into two groups. Patients allocated into Group D will receive nebulized dexmedetomidine (0.5mcg per kg) and Group N will receive nebulized normal saline. The study drug will be prepared by an anaesthesiologist not directly involved in the study, as a uniform 5 ml solution. Allocation concealment will be ensured using sequentially numbered opaque sealed envelopes. The study drug will be administered as aerosol using an electric compressor nebulizer in a propped up or semi recumbent position 30 minutes before induction of general anaesthesia. Nebulization will be done with a 200 cm tubing connected from the oxygen port (100 percent oxygen at a flow rate of 10L per min) attached with a nebulisation mask. Nebulization will continue until the entire solution in the nebulizer gets aerosolized (10 to 15 mins). The anaesthetist blinded to the study will record the following parameters, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and SpO2, at the following time points, at baseline (before nebulization), after nebulization but before induction, during laryngoscopy and intubation, at 1 minute, 3 minutes, 5 minutes, 7 minutes and 10 minutes post-intubation. The observations made during the study will be tabulated, graphically depicted whenever possible, statistically analysed and inferences will be drawn to study the effect of airway nebulization with dexmedetomidine (0.5 mcg per kg) on stress response to laryngoscopy and intubation.

 
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