| CTRI Number |
CTRI/2025/04/085866 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
comparing effects of magnesium sulphate nebulization and lignocaine nebulization in reducing postoperativ
sore throat, hoarseness of voice and cough in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparative study of Magnesium sulphate nebulization and Lignocaine nebulization in prevention of postoperative sore throat (POST), Hoarseness of voice and Cough 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 Veena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN Medical college Ajmer, Rajasthan |
| Address |
Department of Anaesthesiology,new OT, 1st floor, JLN hospital, Kalabagh, Ajmer, Rajasthan. India.
Department of Anaesthesiology, new OT,1st floor,JLN hospital,Kalabagh,Ajmer, Rajasthan.
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN Medical college Ajmer, Rajasthan |
| Address |
Department of Anaesthesiology,new OT, 1st floor, JLN hospital, Kalabagh, Ajmer, Rajasthan. India.
Department of Anaesthesiology, new OT,1st floor,JLN hospital,Kalabagh,Ajmer, Rajasthan.
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN Medical college Ajmer, Rajasthan |
| Address |
Department of Anaesthesiology,new OT, 1st floor, JLN hospital, Kalabagh, Ajmer, Rajasthan. India.
Department of Anaesthesiology, new OT,1st floor,JLN hospital,Kalabagh,Ajmer, Rajasthan.
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,new ot, 1st floor,Jawahar Lal medical college and hospital, Ajmer.305001 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology JLN medical college |
| Address |
Kalabagh, Ajmer,Rajasthan,305001 |
| Type of Sponsor |
Government medical college |
|
|
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 GANGUBAI BIRADAR |
Jawahar Lal Nehru medical college |
Department of Anaesthesiology New ot 1st floor, Jawahar Lal Nehru medical college and hospital, Ajmer.305001
Ajmer
RAJASTHAN |
9731753546
gangamb53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru medical college |
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 |
| Intervention |
Nebulization with magnesium sulphate 250mg dilated with 4ml NS (6.25%) |
To see the reduction in incidence and severity of postoperative sore throat,cough and hoarseness of voice in patients undergoing general anaesthesia. |
| Comparator Agent |
Nebulization with Magnesium sulphate 250mg diluted with NS 4ml (6.25%) |
To observe the reduced incidence and severity of postoperative sore throat,cough and hoarseness of voice. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)patients undergoing general anaesthesia in supine position. 2)duration of surgery up to 3 hours 3)ASA physical status 1&2 |
|
| ExclusionCriteria |
| Details |
1)ASA class 3 and above 2)Mallampatti grades more than 2 3) any psychiatric disorders and history of epilepsy 4)neurological patients with raised intracranial pressure 5) patients with known CAD and IHD 6)pregnancy 7) patients sensitive or allergic to study drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess incidence and severity of postoperative sore throat, hoarseness of voice and cough. |
To monitor effects immediately after extubation followed by every 2nd hourly till 6th hours thereafter every 12 hours and 24 hour postoperative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic changes HR,SBP,DBP,MAP & SPO2 Side effects |
Hemodynamic monitoring in 1) prenebulization 2)Preinduction 3)postoperative immediately followed by 2nd hourly till 6th hour & 12th hourly & 24th hour. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/06/2025 |
| 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="0"
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 will be prospective double blind study performed to evaluate and compare efficacy of preoperative magnesium sulphate 250mg and lignocaine 2% nebulization on the incidence and severity of postoperative sore throat, hoarseness of voice and cough in the patients undergoing surgeries under general anaesthesia with endotracheal intubation.primary objective is to assess incidence and severity of postoperative sore throat,hoarseness of voice and cough immediately after extubation followed by evert 2nd hourly till 6th hourly,12th and 24th hour.secondary objectives are haemodynamic changes like HR,SBP,DBP, MAP and SPO2. |