| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - sunetra82@gmail.com
- 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.
- 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. |