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CTRI Number  CTRI/2025/07/089940 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
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 study comparing the effects of Dexmedetomidine vs Magnesium Sulphate nebulisation in reducing sore throat in patients undergoing general anaesthesia 
Scientific Title of Study   Comparison of nebulized Dexmedetomidine vs Magnesium Sulphate for the attenuation of postoperative sore throat in patients undergoing general anaesthesia 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashley Eapen 
Designation  Post graduate student 
Affiliation  Believers Church Medical College Hospital 
Address  Department of Anaesthesia, Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103

Pathanamthitta
KERALA
689103
India 
Phone  8606093091  
Fax    
Email  ashleyeapen18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Litha Mary Mathew 
Designation  Associate Professor 
Affiliation  Believers Church Medical College Hospital 
Address  Department of Anaesthesia, Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103

Pathanamthitta
KERALA
689103
India 
Phone  9447349649  
Fax    
Email  lthmathew@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Litha Mary Mathew 
Designation  Associate Professor 
Affiliation  Believers Church Medical College Hospital 
Address  Department of Anaesthesia, Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103

Pathanamthitta
KERALA
689103
India 
Phone  9447349649  
Fax    
Email  lthmathew@gmail.com  
 
Source of Monetary or Material Support  
Believers Church Medical College Hospital  
 
Primary Sponsor  
Name  Dr Ashley Eapen 
Address  Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103 
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 Ashley Eapen  Believers Church Medical College Hospital  Operation theatre complex, Believers Church Medical College Hospital, St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103
Pathanamthitta
KERALA 
8606093091

ashleyeapen18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Believers Church Medical College Hospital  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  Dexmedetomidine   Dexmedetomidine at a dose of 1 mcg/kg was diluted with normal saline to a total volume of 5 ml in a 5 cc syringe and administered as a single preoperative dose via a nebulisation mask by a trained anaesthetist. The nebulisation was driven by an oxygen source set at 8 L/min and 50 psi, delivered over a period of 15 minutes 
Comparator Agent  Magnesium Sulphate  Magnesium Sulphate at a dose of 250 mg was diluted with normal saline to a total volume of 5 ml in a 5 cc syringe and administered as a single preoperative dose via a nebulisation mask by a trained anaesthetist. The nebulisation was driven by an oxygen source set at 8 L/min and 50 psi, delivered over a period of 15 minutes. 
Intervention  Preoperative Nebulisation with study drugs for prevention of post operative sore throat  Preoperative Nebulisation with Dexmedetomidine or Magnesium Sulphate for prevention of postoperative sore throat 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA-PS I-II
2. Posted for elective surgical procedures in supine position under general
anaesthesia with endotracheal intubation
3.Duration of surgery : 2-5 hours 
 
ExclusionCriteria 
Details  1. Patients who refuse or lack the capacity to give consent
2. History of preoperative sore throat, respiratory tract infection,
chronic lung diseases
3. Known allergy to the study drug
4. Pregnancy
5. Anticipated difficult airway
6. BMI greater than 30 kg/m2
7. Patients undergoing oral, nasal, head and neck surgeries
8. Requiring more than one attempt at intubation 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of the sore throat, hoarseness of voice and cough in the postoperative period in patients prophylactically treated with Dexmedetomidine or Magnesium Sulphate undergoing elective surgeries under general anaesthesia with tracheal intubation   Postoperatively at 0, 2, 4 and 6 hours from the time of extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effects of nebulization of the study drugs on respiratory rate and hemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure  Postoperatively at 0, 2, 4 and 6 hours from the time of extubation 
 
Target Sample Size   Total Sample Size="206"
Sample Size from India="206" 
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)   15/07/2025 
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="7"
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 - None of the above

  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 - Proposals should be directed to [ashleyeapen18@gmail.com].

  6. For how long will this data be available start date provided 23-03-2028 and end date provided 23-03-2035?
    Response - Immediately following publication. No end date.

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

Postoperative sore throat (POST) is a common complication following surgeries performed under general anaesthesia. The incidence of POST in patients undergoing tracheal intubation for general anaesthesia (GA) is 6.6-90 percentage. It is a double-blind randomized controlled trial to compare the effects of Dexmedetomidine and Magnesium Sulphate nebulisations on attenuation of sore throat, hoarseness of voice and cough in the postoperative period in patients undergoing elective surgeries under general anaesthesia with tracheal intubation. Patients fulfilling the inclusion criteria will be enrolled in the study and assessed prior to surgery. Predisposing factors such as cigarette smoking, gastroesophageal reflux disease, long-term use of corticosteroids and non-steroidal anti-inflammatory drugs will be captured. Patients will be informed about the study and informed consent will be obtained.

Participants will be randomly allocated into two groups using the fishbowl technique.One group will receive Dexmedetomidine at a dose of 1 mcg/kg, while the other group will receive 250 mg of Magnesium Sulphate. Dexmedetomidine (brand name: Dexem) and Magnesium Sulphate (brand name: Magneon) are available in the form of intravenous injection solutions, supplied in ampoules. They are diluted with normal saline for use via nebulisation. Both will be diluted with normal saline to a 5 mL solution in a 5 cc syringe and administered by a trained anaesthetist through a nebulization mask connected to wall-mounted, oxygen driven source (8 L/min, 50 psi) for 15 min. General anaesthesia (GA) will be induced after completing nebulization. Sore throat, hoarseness of voice, cough, haemodynamic parameters and respiratory rate will be measured at 0, 2, 4 and 6 hours from the time of extubation. POST would be graded on a four-point scale (0–3). This study seeks in formulating interventions for decreasing sore throat, cough and hoarseness of voice in the postoperative period that would help to improve the quality of postoperative recovery.

 
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