| CTRI Number |
CTRI/2026/01/100599 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing efficacy of two medications, Magnesium Sulphate versus Lidocaine Nebulization for Preventing Sore Throat in Patients undergoing surgeries under General Anaesthesia |
|
Scientific Title of Study
|
Comparative Evaluation of post operative sore throat after nebulization with magnesium sulphate versus lidocaine 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 |
Niveditha Kishore Srinivasan |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| Address |
Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9004074040 |
| Fax |
|
| Email |
niveditha2899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Niveditha Kishore Srinivasan |
| Address |
Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| 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 |
| Niveditha Kishore Srinivasan |
Dr. D.Y. Patil Hospital |
Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9004074040
niveditha2899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj Lignocaine 2% |
preoperative nebulization with Lignocaine 2% (5ml) |
| Intervention |
inj Magnesium sulphate |
preoperative Nebulization with Magnesium Sulphate (500mg) [1ml of MgSO4 diluted in 4ml of Normal Saline(NS)] |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1- American Society of Anaesthesiology (ASA) grade I and II
2- Hemodynamically stable patients with all routine investigations within the normal limits.
3- Patients who give informed written consent and are willing to be a part of the study.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal to be a part of the study
2. History of allergy to the drug being used in the study
3. Patients with severe cardiovascular or respiratory disorders
4. Patients with difficult airway or requiring nasal intubation
5. Patients on steroid therapy
6. Subjects who cough or bucked before extubation
7. Surgeries involving oral cavity, airway, head and neck surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of post operative sore throat after nebulization with magnesium sulphate versus lidocaine in patients undergoing general anaesthesia requiring endotracheal intubation
|
Incidence of sore-throat in both groups at 0, 2, 4, 6, 12, 24 hours post-surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess effect of nebulisation with magnesium sulphate and lidocaine on haemodynamic parameters
2. To assess post operative sedation
3. Overall patient comfort post-surgery
4. Any drug related side effects.
|
1. Haemodynamic parameters - HR, SBP, DBP, MAP and SpO2 will be observed-
A. just prior to administering nebulisation
B. at the time of induction of GA
C. at the time of extubation
2. Post operative sedation as per Ramsay sedation score
3. Any postoperative side effect or complications
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/01/2026 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This is a Prospective, double-blind, Randomized Control Trial to compare the incidence of post operative sore throat after nebulization with magnesium sulphate versus lidocaine in patients undergoing general anaesthesia requiring endotracheal intubation, to assess effect of nebulisation with magnesium sulphate and lidocaine on haemodynamic parameters, post operative sedation overall patient comfort post-surgery and any drug related side effects. Incidence of sore-throat in both groups will be observed at 0, 2, 4, 6, 12, 24 hours post-surgery.Haemodynamic parameters - HR, SBP, DBP, MAP and SpO2 will be observed just prior to administering nebulisation, at the time of induction of GA and at the time of extubation Post operative sedation will be assessed as per Ramsay sedation score Any postoperative side effect or complications will be noted |