| CTRI Number |
CTRI/2026/01/102298 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
PROSPECTIVE RANDOMIZED CONTROL DOUBLE BLINDED TRAIL ON PREOPERATIVE ORAL ZINC TABLET DECREASING INCIDENCE OF POSTOPERATIVE SORE THROAT |
|
Scientific Title of Study
|
PROSPECTIVE RANDOMIZED CONTROL DOUBLE BLINDED TRAIL ON PREOPERATIVE ORAL ZINC TABLET DECREASING INCIDENCE OF POSTOPERATIVE SORE THROAT |
| 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 JALAJA K R |
| Designation |
SENIOR CONSULTANT, |
| Affiliation |
MANIPAL HOSPITALS, OLD AIRPORT ROAD,BANGLORE |
| Address |
DEPARTMENT OF ANESTHESIOLOGY MANIPAL HOSPITALS
OLD AIRPORT ROAD
BANGLORE 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9945515223 |
| Fax |
|
| Email |
jalaja1975@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VISHWANATH SIDDINI |
| Designation |
MEMBER SECRETARY |
| Affiliation |
MANIPAL HOSPITALS OLD AIRPORT ROAD |
| Address |
ETHICS COMMITTEE OF MANIPAL
MANIPAL HOSPITALS
OLD AIRPORT ROAD
BANGLORE 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9845174866 |
| Fax |
|
| Email |
vishwanathsid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VISHWANATH SIDDINI |
| Designation |
MEMBER SECRETARY |
| Affiliation |
MANIPAL HOSPITALS OLD AIRPORT ROAD |
| Address |
ETHICS COMMITTEE OF MANIPAL
MANIPAL HOSPITALS
OLD AIRPORT ROAD
BANGLORE 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9845174866 |
| Fax |
|
| Email |
vishwanathsid@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal hospital |
| Address |
MANIPAL HOSPITAL, 98, rustumbag
OLD AIRPORT ROAD
Banglore - 560017
BANGLORE |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Akarshika Jeyaraman |
Manipal hospitals banglore |
Department of anesthesiology.
Manipal hospitals, rustumbag old airport road, banglore - 560017
Bangalore
KARNATAKA |
9442138122
akarshika30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of manipal hospital, banglore |
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 |
| Comparator Agent |
Placebo |
Giving placebo tablet to patients undergoing surgery general anesthesia with endotracheal tube |
| Intervention |
Zinc tablet |
Giving zinc premedication to patients undergoing surgery under general anesthesia with endotracheal tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anesthesiologists grade 1 and 2 aged 18-60 years, posted for surgeries lasting greater than 1 hour and less than 6 hour duration under general anesthesia requiring tracheal intubation will be included for the study |
|
| ExclusionCriteria |
| Details |
1. Smokers
2. Pregnant patients
3. Patients with recent history of sore throat
4. Malampatti grade greater than 2
5. Patients with zinc allergy
6. Traumatic or more than one attempt of intubation
7. Cormack-lehane score 3 and 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary aim of our study will be to assess the incidence of POST at 4 hours after surgery after zinc 40mg premedication |
Primary aim of our study will be to assess the incidence of POST at 4 hours after surgery after zinc 40mg premedication |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
16/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/02/2026 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [akarshika30@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Post operative sore throat (POST) is a common complaint in patients recieving general anesthesia. Although symptoms often ameliorate without any treatment, prophylactic management improves patient satisfaction and impacts discharge from hospital.Zinc is a micronutrient with anti-inflammatory and antioxidant property which promotes growth, tissue repair and modulates immune system. As a topical agent zinc has been used for prevention of oral mucositis in patients receiving high dose chemotherapy. Oral zinc tablets has been shown to reduce the incidence and severity of POST. Zinc also prevents the cytokine release, decreases the reactive oxygen species, and subsequently decreases cyclooxygenase two expression, and prostaglandin E two release. We hypothesized administration of oral zinc in form of dispersible tablet will reduce the incidence of POST due to its inherent anti-inflammatory and tissue healing properties. To test the hypothesis this study was designed to investigate the efficacy of oral zinc sulfate given 30 minutes preoperatively in reducing POST till 24 hours after surgery, where POST was caused by endotracheal intubation. The dispersible tablet form of zinc was preferred due to its easy availability in our country and comparatively better local effect on oropharyngeal mucosa. The primary aim of our study will be to assess the incidence and severity of POST . The secondary aim will be to assess for any side effects such as nausea, vomiting, metallic taste, diarrhea.
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