| CTRI Number |
CTRI/2024/04/065839 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study between two different drugs, Magnesium, and Zinc to find out their effect in reducing post-operative sore throat after general anesthesia. |
|
Scientific Title of Study
|
Efficacy and Safety of Oral Magnesium vs. Oral Zinc in the Post-Operative Sore Throat (POST): A Prospective, Randomized, Double-blind, Placebo-Controlled Study
|
| 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 Sumit Bansal |
| Designation |
Assistant Professor AIIMS Rajkot |
| Affiliation |
AIIMS, Rajkot |
| Address |
Department of Anaesthesia, AIIMS, Rajkot
Rajkot
GUJARAT
360005
India |
| Phone |
9968720446 |
| Fax |
|
| Email |
sumitbansal05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Bansal |
| Designation |
Assistant Professor AIIMS Rajkot |
| Affiliation |
AIIMS, Rajkot |
| Address |
Department of Anaesthesia, AIIMS, Rajkot
Rajkot
GUJARAT
360005
India |
| Phone |
9968720446 |
| Fax |
|
| Email |
sumitbansal05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Bansal |
| Designation |
Assistant Professor AIIMS Rajkot |
| Affiliation |
AIIMS, Rajkot |
| Address |
Department of Anaesthesia, AIIMS, Rajkot
Rajkot
GUJARAT
360005
India |
| Phone |
9968720446 |
| Fax |
|
| Email |
sumitbansal05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sumit Bansal
AIIMS Rajkot |
|
|
Primary Sponsor
|
| Name |
Dr Sumit Bansal |
| Address |
AIIMS Rajkot |
| 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 Sumit Bansal |
AIIMS Rajkot |
Department of Anaesthesia, AIIMS, Rajkot (Gujarat)
Rajkot
GUJARAT |
9968720446
sumitbansal05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post Operative Sore Throat |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo will be given to compare with Zinc and Magnesium |
| Intervention |
Zinc and magnesium |
Zinc and magnesium supplements will be compared with placebo for prevention of post operative sore throat after general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
|
|
| ExclusionCriteria |
| Details |
1) History of preoperative sore throat, common colds, upper respiratory infections, immune deficiencies
2) Chronic smokers
3) Patients with Mallampati airway grade of more than 2
4) Patients requiring more than one attempt for intubation or traumatic intubations
5) Patients requiring laryngeal mask Airway (LMA) placement
6) Patients allergic to zinc or magnesium
7) Patients undergoing head and neck surgeries
8) Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurence of POST at 4 hours. |
Occurence of POST at 4 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity of POST at 0, 2 & 24 hours after the surgery.
Number of adverse effects in all three groups also recorded in secondary outcome. |
Till 24 hour post surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
16/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Postoperative sore throat (POST) is the second most common complication after general anesthesia which causes discomfort to the patient. Currently, there is no effective treatment which reduces the occurence and severity of post-sore throat after general anaesthesia. The current study is planned to assess the effect and safety of zinc and magnesium in reducing the occurence and severity of POSTAfter taking the informed consent, 2 hour prior to general anaesthesia participants will be asked to take 5 ml of water in which the study drug is dissolved as per group allocation. (Zn/Mg/or plain water). The rest of the procedure will be as per standard care of the operation. After operation, participant will be evaluated for post operative sore throat and adverse drug events at 0, 2, 4 and 24 hours. |