FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/01/049232 [Registered on: 25/01/2023] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of effectiveness of steroid v/s trial drug given by inhalation before surgery to suppress sore throat that is seen after general anaesthesia  
Scientific Title of Study   COMPARISON OF EFFECTIVENESS OF NEBULIZED DEXAMETHASONE V/S NEBULIZED DEXMEDETOMIDINE IN PREVENTION OF POST OPERATIVE SORE THROAT AFTER GENERAL ENDOTRACHEAL ANAESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nadashree A S 
Designation  Post graduate Student  
Affiliation  SIMS SHIMOGA  
Address  Department of Anaesthesiology, Major OT complex, 3rd floor, McGann District teaching Hospital, SIMS, Shimoga
Department of Anaesthesiology, Major OT complex, 3rd floor, McGann District teaching Hospital, SIMS, Shimoga
Shimoga
KARNATAKA
577201
India 
Phone  09945816544  
Fax    
Email  asnadashree@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashwini S 
Designation  Associate Professor  
Affiliation  SIMS SHIMOGA  
Address  Department of Anaesthesiology, Major OT complex, 3rd floor, McGann District teaching Hospital, SIMS,SHIMOGA
Department of Anaesthesiology, Major OT complex, 3rd floor, McGann District teaching Hospital, SIMS,SHIMOGA
Shimoga
KARNATAKA
577201
India 
Phone  09945816544  
Fax    
Email  ashwini.satrasala@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nadashree A S 
Designation  Post graduate Student  
Affiliation  SIMS SHIMOGA  
Address  Department of Anaesthesiology, Major OT complex, 3rd floor, McGann District teaching Hospital, SIMS,SHIMOGA
Department of Anaesthesiology, Major OT complex, 3rd floor, McGann District teaching Hospital, SIMS,SHIMOGA
Shimoga
KARNATAKA
577201
India 
Phone  09945816544  
Fax    
Email  asnadashree@gmail.com  
 
Source of Monetary or Material Support  
MCGANN TEACHING DISTRICT HOSPITAL, SIMS SHIMOGA  
 
Primary Sponsor  
Name  Dr Nadashree A S 
Address  PG GIRLS HOSTEL SHIMOGA INSTITUTE OF MEDICAL SCIENCES 
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 Nadashree A S  McGann Hospital   Department of Anaesthesiology, Major OT complex, 3rd floor, McGann District teaching Hospital, SIMS,SHIMOGA 577201
Shimoga
KARNATAKA 
09945816544

asnadashree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC SIMS  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 
Comparator Agent  DEXAMETHASONE   Group 1-will receive nebulization of 8mg(2ml) of Dexamethasone diluted to 5ml using Normal saline once for 15 minutes  
Intervention  DEXMEDETOMIDINE   Group 2-will receive nebulization of 50 microgram(0.5ml) of Dexmedetomidine diluted to 5ml using Normal saline once for 15 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age between 18-65 years of either sex belonging to ASA-I-II.
2.Elective surgery in supine position requiring general anaesthesia with endotracheal
intubation.

 
 
ExclusionCriteria 
Details  1.Pre operative sore throat or cold
2.Intraoral surgeries
3.Asthma, COPD
4.Known allergies to study drug
5.Pregnant patients
6.Anticipated difficult airway

 
 
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 
Assessment of post operative sore throat graded on 4 point scale (0-3)

0-No sore throat
1-Mild sore throat(upon asking only patient complaints of sore throat)
2-Moderate sore throat (patient himself complaints of sore throat)
3-Severe sore throat (change of voice or hoarseness associated with throat pain) 
At 0th hour and then at 2nd, 6th, 12th, 24th hour  
 
Secondary Outcome  
Outcome  TimePoints 
Attenuation of hemodynamic stress response to laryngoscope and intubation   5 minutes 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2023 
Date of Study Completion (India) 31/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/03/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Yet to submit for publication 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
A prospective, randomised comparative study titled “COMPARISON OF
EFFECTIVENESS OF NEBULIZED DEXAMETHASONE V/S NEBULIZED
DEXMEDETOMIDINE IN PREVENTION OF POST OPERATIVE SORE
THROAT AFTER GENERAL ENDOTRACHEAL ANAESTHESIA” was
conducted at McGann Teaching District Hospital attached to Shimoga Institute of
Medical Sciences, Shivamogga from October 2022 to March 2024.The study was
conducted on 100 subjects undergoing elective surgeries requiring general anaesthesia
with endotracheal intubation technique, after obtaining clearance from Institutional
Ethical Committee and Informed Consent was taken from all the subjects involved in
the study.
100 patients scheduled for various elective surgical procedures belonging to
ASA physical status 1 and 2; age group of 18-60 years were included in the present
study. Patients with pre operative sore throat or cold ;undergoing intraoral surgeries;
patients with Asthma/COPD; known allergies to study drug ;Pregnant patients
;Anticipated difficult airway were excluded from the study.
The patients were randomly allocated into two groups of 50 each:
Group 1- received nebulization of 8mg(2ml) of Dexamethasone diluted to 5ml
using Normal saline.
Group 2- received nebulization of 50 microgram(0.5ml) of Dexmedetomidine
diluted to 5ml using Normal saline.Pre-anaesthetic evaluation was done on the previous day and informed consent
was obtained. IV line was secured. The study drug was given by nebulization for 15
minutes in the preoperative room.Pre nebulization and post nebulization hemodynamic
parameters were noted. Patients were shifted to operating room. ASA standard monitors
(ECG,Pulse oximeter, NIBP, Temperature and end tidal CO2 ) were attached. 15
minutes after the completion of nebulization, General anaesthesia was provided.
Premedication with injection midazolam 0.02mg/kg, injection fentanyl 2 microgram/kg
and induction with injection propofol 2mg/kg after preoxygenation with 100 % O2 for
3 minutes through face mask was done. Tracheal intubation was facilitated with
injection vecuronium 0.1mg/kg IV. All patients were intubated with sterile cuffed
polyvinyl chloride tubes of appropriate size. The tracheal cuff was then inflated with
air to cuff pressure of 20cm H2O and thereafter cuff pressure was checked every 15
minutes to maintain the same pressure till the end of surgery.
After confirmation of tracheal tube position anaesthesia was maintained with
O2, N2O, isoflurane and intermittent doses of vecuronium and ventilated using IPPV.
Injection ondansetron 4mg IV was given 30 minutes before the end of the procedure.
At the end of the surgery gentle suctioning of oropharynx was done. Then inspiratory
O2 concentration was kept at 100%. The residual neuromuscular block was reversed
with 50microgram /kg of neostigmine and 10microgram/kg glycopyrrolate and patient
was extubated.
 After extubation, patient was shifted to recovery room where patients was
assessed for sore throat at 0th hour, then at 2nd, 6th, 12th, 24th hr in post operative ward
and graded on 4 point scale (0-3).The hemodynamic parameters such as HR,SBP,DBP and MAP were recorded
before nebulisation, after nebulisation,before intubation, immediately after intubation-
0
th minute, 2nd minute and 5th minute post-intubation.
There was no significant statistical difference at 0th, 2nd, 12th, 24th hour in terms
of incidence and severity of postoperative sore throat.
There was statistically significant fall in heart rate in Dexmedetomidine group
compared to Dexamethasone group after nebulisation during all time intervals in the
study period except second minute after intubation.
There was statistically significant fall in systolic blood pressure and mean
arterial pressure , 2nd minute after intubation in Dexmedetomidine group compared to
Dexamethasone group.
There was no statistically significant difference with respect to diastolic blood
pressure in both the groups at all time intervals in the study period.
Hence, Dexmedetomidine 50mcg given as nebulization preoperatively 15
minutes before induction of anaesthesia is as effective as nebulized Dexamethasone
8mg in prevention of post operative sore throat without any significant bradycardia and
hypotension. Nebulized dexmedetomidine also has an added advantage of attenuation
of haemodynamic stress response to laryngoscopy and endotracheal intubation.
 
Close