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CTRI Number  CTRI/2025/09/094028 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
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 the efficacy of nebulized magnesium sulphate versus dexamethasone in preventing post-operative sore throat after general anaesthesia 
Scientific Title of Study   Comparison of the efficacy of nebulized magnesium sulphate versus dexamethasone in preventing post-operative sore throat following endotracheal intubation in patients undergoing laparoscopic surgeries- A double-blinded, randomized 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  Dr Sunetra Sunder 
Designation  1st year PG student 
Affiliation  Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry  
Address  Room no 106 Departmment of Anaesthesiology Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  7092205640  
Fax    
Email  sunetra82@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suneeth P Lazarus 
Designation  Professor, HOD 
Affiliation  Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry  
Address  Room no 107 Departmment of Anaesthesiology Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  9894332543  
Fax    
Email  lazarus.suneeth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunetra Sunder 
Designation  1st year Post-graduate  
Affiliation  Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry  
Address  Room no 106 Departmment of Anaesthesiology Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  7092205640  
Fax    
Email  sunetra82@gmail.com  
 
Source of Monetary or Material Support  
Sri Manakula Vinayagar Medical College Hospital Kalitheerthalkuppam Madagadipet Puducherry 605107 
 
Primary Sponsor  
Name  Sunetra Sunder 
Address  Room no 106 Sri Manakula Vinayagar Medical College Hospital Kalitheerthalkuppam Madagadipet Puducherry 605107 
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 Sunetra Sunder  Sri Manakula Vinayagar Medical College Hospital  Sri Manakula Vinayagar Medical College Hospital Kalitheerthalkuppam Madagadipet Puducherry
Pondicherry
PONDICHERRY 
7092205640

sunetra82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH- Ethics Committee  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexamethasone  Dexamethasone 8 mg (2mL) with 3mL normal saline for nebulization 30 minutes before induction of anaesthesia in the preoperative receiving room 
Intervention  Magnesium sulphate  Magnesium sulphate (50% W/V 2mL) with 3mL normal saline for nebulization 30 minutes before induction of anaesthesia in the preoperative receiving room 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients providing written informed consent
Adults aged 18 to 60 years
ASA Physical Status I or II
Elective laparoscopic abdominal surgeries under general anaesthesia with endotracheal intubation
 
 
ExclusionCriteria 
Details  Pre existing sore throat, upper respiratory tract infection (URTI), or vocal cord pathology
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 
To compare the efficacy of nebulized magnesium sulphate versus dexamethasone in preventing post-operative sore throat (POST)  0-24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the incidence of associated post-operative nausea, vomiting (PONV) in both groups
To evaluate the changes in haemodynamic profile in both groups
 
0-24 hours
0-120 minutes 
 
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 2 
Date of First Enrollment (India)   10/09/2025 
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="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

  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) -  sunetra82@gmail.com

  6. For how long will this data be available start date provided 30-12-2026 and end date provided 18-12-2029?
    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  

A total of 64 patients scheduled for elective laparoscopic abdominal surgeries under general anaesthesia will be included. Participants will be randomly allocated into two groups based on 1:1 allocation ratio using block randomization technique. Web-based block generation will be done through https://sealedenvelope.com/ and used for patient allocation into:

·       Group A: Patients receiving nebulized magnesium sulphate.

·       Group B: Patients receiving nebulized dexamethasone.

 

 

The size of the block will be decided by a staff member and kept blinded from the investigator in a separate sealed document to avoid selection bias. Patient’s allocation will be kept concealed in a separate sealed envelope and revealed after measurement of the baseline values and before the procedure.

 

Group A will receive magnesium sulphate (50% W/V 2mL) with 3mL normal saline for nebulization 30 minutes before induction of anaesthesia in the preoperative receiving room.

Group B will receive dexamethasone 8 mg (2mL) with 3mL normal saline for nebulization 30 minutes before induction of anaesthesia in the preoperative receiving room.

 

Both medications will be administered via mask nebulization approximately 30 minutes before induction of anaesthesia. The nebulization will be performed by a nurse unaware of group allocation, ensuring blinding. All intubations will be performed by qualified anaesthesiologists.

 

All patients will be premedicated with tablet pantoprazole 40mg and alprazolam 0.5mg night before the surgery. All patients will be kept nil per oral overnight.

 

After receiving nebulization in the receiving area, patient will be shifted to OT. All ASA standard monitors like HR, NIBP, SpO2, EtCO2 will be attached. Baseline vitals will be recorded. Patient will be preoxygenated for 4 minutes with 8L O2. Patient will be premedicated with Inj. Glycopyrrolate 0.01mg/kg IV, sedated with Inj. Midazolam 0.02mg/kg IV. Inj. Xylocaine 1.5mg/kg IV and Inj. Fentanyl 2mcg/kg IV will be given. Patient will be induced with Inj. Propofol 2mg/kg IV. Muscle relaxation with non-depolarizing muscle relaxant Inj. Atracurium 0.5mg/kg IV will be done. Using an appropriate size polyvinylchloride (PVC) endotracheal tube, patient will be intubated as smooth direct laryngoscopy by an experienced anaesthesiologist. ET tube will be fixed after 5-point auscultation and confirming bilateral air entry. Immediately after intubation, cuff pressure will be measured and monitored every 60 minutes, ensuring cuff pressure is maintained less than 30cm H2O.

 

 

Adequate depth of anaesthesia will be achieved. Depth of anaesthesia will be maintained with 33% O2, 66% N2O and 1 MAC sevoflurane. Haemodynamics of the patient will be monitored every 15 minutes intraoperatively. 20 minutes before the procedure, Inj. Ondansetron 4mg IV will be given to prevent post-operative nausea and vomiting. After gentle adequate oral suctioning with soft tip suction catheter, patient’s breathing efforts will be noted. Neuromuscular blockade reversal with Inj. Neostigmine 0.05mg/kg IV and Inj. Glycopyrrolate 0.01mg/kg IV will be given. Smooth extubation will be done when the patient is fully awake.

 

Patients will be assessed in the post-operative ward by a nursing staff blinded for the study. Incidence of sore throat, pain, discomfort and other related symptoms will be assessed after shifting the patients to post-operative ward at 0-hour, 4-hour, 8-hour, 12-hour and 24-hour according to the POST severity grading score. Total incidence of POST will be calculated by the ratio of number of patients who experienced sore throat at least once to the total number of patients. The patients will be then followed-up to monitor any other post-operative complications and such findings will be recorded.

 
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