| CTRI Number |
CTRI/2025/04/084149 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| 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
|
Effect of pre-operative nebulisation of magnesium sulphate for reducing the incidence of post operative sore throat |
|
Scientific Title of Study
|
Comparison of two different doses of pre-operative nebulisation of magnesium sulphate in reducing the incidence of post operative sore throat following endotracheal intubation in patients undergoing surgery under 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 Khullar Kamnong |
| Designation |
Post graduate student |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesiology, Sardar Patel Medical College, Bikaner, Rajasthan
PBM hospital, Bikaner, Rajasthan-334001
Bikaner
RAJASTHAN
334001
India |
| Phone |
7005763983 |
| Fax |
|
| Email |
kamnong2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiwi Mantan |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesiology, Sardar Patel Medical College, Bikaner, Rajasthan
PBM hospital, Bikaner, Rajasthan-334001
Bikaner
RAJASTHAN
334001
India |
| Phone |
9929092702 |
| Fax |
|
| Email |
kiwivyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiwi Mantan |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anaesthesiology, Sardar Patel Medical College, Bikaner, Rajasthan
PBM hospital, Bikaner, Rajasthan-334001
Bikaner
RAJASTHAN
334001
India |
| Phone |
9929092702 |
| Fax |
|
| Email |
kiwivyas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College, Bikaner Rajasthan-334001 |
|
|
Primary Sponsor
|
| Name |
Dr. Khullar Kamnong |
| Address |
Department of Anaesthesiology, PBM hospital, Bikaner, Rajasthan-334001 |
| 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 Khullar Kamnong |
Sardar Patel Medical College |
Department of Anaesthesiology, PBM hospital, Bikaner, Rajasthan-334001
Bikaner
RAJASTHAN |
7005763983
kamnong2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical and Research Board, Sardar Patel medical college, Bikaner, Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preoperative nebulization of magnesium sulfate to decrease the incidence of post operative sore throat |
Pre-operative nebulisation of magnesium sulphate 500mg in reducing the incidence of post operative sore throat following endotracheal intubation in patients undergoing surgery under general anaesthesia |
| Comparator Agent |
Preoperative nebulization of normal saline to decrease the incidence of post operative sore throat |
Pre-operative nebulisation of normal saline in reducing the incidence of post operative sore throat following endotracheal intubation in patients undergoing surgery under general anaesthesia |
| Intervention |
Preoperative nebulization of magnesium sulfate to decrease the incidence of post operative sore throat |
Pre-operative nebulisation of magnesium sulphate 250mg in reducing the incidence of post operative sore throat following endotracheal intubation in patients undergoing surgery under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 to 65 years, American society of anaesthesiologists grading 1 and 2, Mallampati scoring 1 and 2, duration of surgery more than 1 hour |
|
| ExclusionCriteria |
| Details |
Patient refusal, allergy to drugs, head and neck surgery, American society of anaesthesiologists grade 3 and 4, patients with upper respiratory tract infection, neuromuscular diseases, patients with nasal and throat pack, age less than 20yrs and more than 65years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Post operative sore throat at rest
2. Post operative sore throat on swallowing |
0hours, 2 hours, 4hours, 6hours, 10hours, 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Laryngeal complaints such as cough, hoarseness of voice, nausea and vomiting, respiratory depression and hypotension |
0hours, 2 hours, 4hours, 6hours, 10hours, 24hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this study, we will compared two different doses of pre-operative nebulisation of magnesium sulphate in reducing the incidence of post operative sore throat following endotracheal intubation in patients undergoing surgery under general anaesthesia. Incidence of post operative sore throat will be examined at rest and on swallowing at different interval of times at 0hr, 2hrs, 4hrs, 6hrs, 10hrs and 24hrs. Apart from incidence of post operative sore throat, other laryngeal complaints such as cough, hoarseness of voice, nausea and vomiting, respiratory depression and hypotension will also examine. |