| CTRI Number |
CTRI/2024/11/077022 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare preoperative magnesium sulphate versus zinc sulphate gargle for prevention of postoperative sore throat |
|
Scientific Title of Study
|
A randomized, double-blind, comparative study of preoperative magnesium sulphate versus zinc sulphate gargle for prevention of postoperative sore throat following endotracheal intubation |
| 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 Patrick Laldinliana |
| Designation |
Resident Doctor |
| Affiliation |
Vilasrao Deshmukh Government Medical College |
| Address |
Department of Anaesthesiology, First Floor, Surgical Building, Government Medical College, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
7073593014 |
| Fax |
|
| Email |
patiemma07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joshi Vyankatesh Shridharacharyaa |
| Designation |
Associate Professor |
| Affiliation |
Vilasrao Deshmukh Government Medical College |
| Address |
Department of Anaesthesia, VDGMC, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9049481707 |
| Fax |
|
| Email |
vyankatesh93@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joshi Vyankatesh Shridharacharyaa |
| Designation |
Associate Professor |
| Affiliation |
Vilasrao Deshmukh Government Medical College |
| Address |
Department of Anaesthesia, VDGMC, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9049481707 |
| Fax |
|
| Email |
vyankatesh93@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Vilasrao Deshmukh Government medical College, Civil Hospital, Latur, Maharashtra, India. 413512 |
|
|
Primary Sponsor
|
| Name |
Vilasrao Deshmukh Government Medical College Latur |
| Address |
Latur, Maharashtra, India
413512 |
| 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 Patrick Laldinliana |
Vilasrao Deshmukh Government Medical College |
ENT OT, Obstetric and Gynaecology OT, General Surgery OT, First floor,
Latur
MAHARASHTRA |
7073593014
patiemma07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VDGMC, Latur |
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 |
Magnesium sulphate solution (20mg/kg dissolved in 20 ml of 5% dextrose.
Intervention (gargles of magnesium sulphate solution) for 15 seconds.
Given 15 minutes before induction of anaesthesia |
| Comparator Agent |
Zinc Sulphate |
Zinc sulphate solution (containing 40 mg of elemental zinc dissolved in 20 ml of 5% dextrose solution)
Intervention (gargles of zinc sulphate solution) for 15 seconds.
Given 15 minutes before induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologists (ASA) physical status I & II.
Patients undergoing elective surgeries under general anaesthesia with endotracheal intubation.
Those willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Age more than 60 or less than 18 years.
Patients having chronic cough, sore throat preoperatively and allergy to the study drug.
Patient of ASA grade 3 and above.
Pregnant females.
Patient with surgeries around airway
Patients with anticipated difficult intubation or with risk of aspiration of gastric contents |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sore throat |
Time after extubation at start, then at 2, 4, 6, 12 and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic changes- HR, SBP, DBP, MAP |
Time since induction of anaesthesia , intraoperatively at the interval of every 15 minutes & after extubation at start, then at 2, 4, 6, 12 & 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
02/12/2024 |
| 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="2"
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
|
Primary purpose: Post operative sore throat is a common undesirable consequence of tracheal intubation. The primary purpose of my protocol is to reduce the incidence of post operative sore throat by means of providing pre operative gargle with either magnesium sulphate or zinc sulphate gargle. Postoperative sore throat remains a significant issue, with 20-74% of patients still suffering, despite the availability of pharmacological and non-pharmacological agents. Our goal as anaesthesiologists is to prevent this problem efficiently and cost-effectively.
Hypothesis: For this study null hypothesis is that there is no significant difference in the incidence of post operative sore throat with magnesium sulphate and zinc sulphate gargle. |