| CTRI Number |
CTRI/2022/11/047707 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of Magnesium Sulphate Nebulization On Incidence Of Post Operative Sore Throat |
|
Scientific Title of Study
|
Effect Of MgSO4 Nebulization On Incidence Of Post Op Sore Throat |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
THAKRANI VIMAL PRAVINBHAI |
| Designation |
Post Graduate Resident |
| Affiliation |
B.J. Medical college, Civil Hospital |
| Address |
F3,First floor, Department of anaesthesiology, B.J. Medical college Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09265095179 |
| Fax |
|
| Email |
vimalpatel29541@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anisha Chokshi |
| Designation |
Associate professor |
| Affiliation |
B.J.Medical college, Civil hospital, Ahmedabad |
| Address |
F3,First floor, Department of anaesthesiology, B.J. Medical college Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824497076 |
| Fax |
|
| Email |
abhinisha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anisha Chokshi |
| Designation |
Associate professor |
| Affiliation |
B.J. Medical college, Civil hospital, Ahmedabad |
| Address |
F3,First floor, Department of anaesthesiology, B.J. Medical college Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824497076 |
| Fax |
|
| Email |
abhinisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Hospital , Asarwa -380016 , Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
Health and family welfare department, Sachivalay, Gandhinagar |
| 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 |
| Vimalkumar Pravinbhai Thakrani |
B. J. Medical college and Civil hospital, Asarwa |
F3,First floor, Department of anaesthesiology, B.J. Medical college Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT |
09265095179
vimalpatel29541@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics 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 |
| Intervention |
Magnesium sulphate |
Nebulised with 3 mL (300 mg) Inj.MgSO4[Inj. MgSO4 (500 mg/mL), 1mL MgSO4 diluted in 5mL distilled water and 3 mL of preparation was given as nebulisation in Pre operative area for 3-5 minutes for 1 time. |
| Comparator Agent |
Normal Saline (0.9%) |
Nebulized with 3 mL of inj. 0.9% normal saline in Pre operative area for 3-5 minutes for 1 time.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II , elective surgery less than 2 hours |
|
| ExclusionCriteria |
| Details |
ASA III, IV , V. , Negative consent, comorbidity patients, pre-existing sore throat. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre op nebulization with MgSO4 , Less Time for laryngoscopy, Short Surgery time helpful in prevention of postoperative sore throat. |
Continues monitoring of vitals and ask about sore throat for 24 hours after Extubation.eg.0 hours, 2 hours, 4 hours, 6 hours, 8 hours, 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sore throat grading applied (Grade 0-3) |
Measured every 2 hourly upto 8 hours and than at 24 hour. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/11/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sore throat related to orotracheal tube might be a consequence of localized trauma, leading to aseptic inflammation of the pharyngeal mucosa. Magnesium being an NMDA receptor antagonist, has a role in preventing NMDA receptor-mediated nociception and inflammation and thereby POST. Nebulization with magnesium sulphate helpful in reduction of severity of postoperative sore throat. |