| CTRI Number |
CTRI/2024/01/061251 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Find Whether Oral Magnesium Or Zinc Is More Effective At Reducing Post Operative Sorethroat Following Neck Operations |
|
Scientific Title of Study
|
To Compare the Efficacy Of Oral Magnesium And Zinc In Decreasing The Incidence Of Post Operative Sorethroat In Thyroid And Parathyroid Surgeries. |
| 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 Jeenu Ann Jose |
| Designation |
Post Graduate Registrar |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Post Graduate Registrar, Department of Anaesthesiology, Christian Medical College, Vellore
Tamil Nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
9495134632 |
| Fax |
|
| Email |
jeenuannjose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Serina Ruth Salins |
| Designation |
Professor and Head of Unit 2 |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Professor and Head of Unit 2 Department of Anaesthesiology, Christian Medical College, Vellore
Tamil Nadu, India.
Professor and Head of Unit 2 Department of Anaesthesiology, Christian Medical College, Vellore
Tamil Nadu, India
Vellore
TAMIL NADU
632004
India |
| Phone |
9442307738 |
| Fax |
|
| Email |
serina.ruth@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeenu Ann Jose |
| Designation |
Post Graduate Registrar |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Post Graduate Registrar, Department of Anaesthesiology, Christian Medical College, Vellore
Tamil Nadu, India.
Vellore
TAMIL NADU
632004
India |
| Phone |
9495134632 |
| Fax |
|
| Email |
jeenuannjose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant CMC Vellore |
|
|
Primary Sponsor
|
| Name |
Fluid Research Grant CMC Vellore |
| Address |
Christian Medical College, Vellore 632004,
Tamil Nadu, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jeenu Ann Jose |
Christian Medical College, Vellore |
Department of Anaesthesiology, Christian Medical College, Vellore-632004,
Tamil Nadu, India.
Vellore
TAMIL NADU |
9495134632
jeenuannjose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E078||Other specified disorders of thyroid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
10 ml of Syrup Magnesium sulphate 10mg will be given to patients 30 mins prior to induction of anaesthesia.It is a one time intervention. |
The composition of the placebo is potassium sorbate, citric acid, xanthan gum, saccharin and purified water.The presence or severity of post operative sore throat will be assessed in patients receiving syrup zinc or magnesium or placebo 30 mins prior to induction. |
| Intervention |
10 ml of Syrup Zinc 5 mg will be given as premedication 30 minutes before anaesthesia induction. It is a one time intervation. |
We will compare which drug is more effective in reducing the incidence of post operative sore throat. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group between 18 to 60 years
2. Patients belonging to American Society of Anesthesiologists Physical Status(ASA-PS) classification 1 and 2
3. Patients undergoing elective thyroid and parathyroid surgeries lasting for 1 to 6 hours
4. Mallampatti grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
1. Mallampati grade of more than 2
2. More than two attempts at intubation
3. History of preoperative sore throat, upper respiratory tract infection
4. common cold or smoking
5. History of allergy to magnesium or zinc
6. Patients receiving chronic treatment of NSAIDs, steroids or magnesium
7. Difficult airway
8. Those requiring fibre optic intubation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of magnesium and zinc syrup in reducing the incidence of Post operative sorethroat at four time intervals 1 hour,4 hour, 12 hour,24 hour after extubation in thyroid and parathyroid surgeries.There is no separate secondary outcome for our study. |
four time intervals 1 hour,4 hour, 12 hour,24 hours from the time of extubation in thyroid and parathyroid surgeries |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of magnesium and zinc syrup in reducing the incidence of Post operative sorethroat at four time intervals 1 hour,4 hour, 12 hour,24 hour after extubation in thyroid and parathyroid surgeries. |
four time intervals 1 hour,4 hour, 12 hour,24 hours from the time of extubation in thyroid and parathyroid surgeries |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
01/02/2024 |
| 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 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
|
A prevalent complication following orotracheal intubation in patients undergoing general anaesthesia is postoperative sore throat. This is due to the mechanical trauma produced by tracheal intubation, as well as the mucosal irritation, inflammation, and edema caused by endotracheal tube cuff pressure. The goal of this study is to evaluate the effectiveness of oral magnesium and zinc in preventing this complication. These medications have anti-nociception, anti-inflammatory, tissue- healing, and tissue-repair properties. It will be a prospective, randomised, double-blind, placebo- controlled study. Participants will be chosen according to the inclusion criteria after receiving their written consent. Using a computer-generated randomization system, a sealed and coded envelope containing oral zinc, magnesium, or a placebo will be distributed. The code will be kept until the conclusion of the investigation.The dose of Zinc sulphate to be used in this study will be 5mg and Magnesium sulphate will be 10 mg.Placebo will be a sucrose solution matching the same taste,colour, and consistency of Zinc and Magnesium syrups. The patient will be instructed to consume the medication 30 minutes before anaesthesia induction. Standard American Society of Anaesthesiologists monitors will be employed in the operating room. After adequate preoxygenation, the patient will be induced with 2mcg/kg of Fentanyl and 2mg/kg of Propofol, followed by orotracheal intubation after neuromuscular blockade has been achieved with 0.5mg/kg of Atracurium. The anesthesiologist will perform laryngoscopy using Macintosh blades 3 or 4, documenting Grades according to the Cormack and Lehane classification, number of attempts, duration of orotracheal intubation, and/or any complications that may have occurred during the procedure. An appropriate sized endotracheal tube according to the patients gender,weight and age will be used and will be standardizing the cuff pressure to 20-25 cm of H2O in all cases.We will be using ETT size of 6.5/7 for female patients and 7/7.5 for male patients. All intubations will be done by Second year post graduades and above. Isoflurane and intermittent doses of atracurium will be used to maintain anaesthesia. Every 30 minutes, the cuff pressure will be measured and maintained between 20 and 25 cm H2O. During surgery, the use of nonsteroidal anti-inflammatory medications and steroids will be documented. Anesthesiologists will perform oropharyngeal suctioning and then do awake extubation of the patient. On arrival in the recovery room, the patient’s severity of sore throat will be assessed using a standardized four-point pain scale. This assessment is a verbal questionnaire which will be taken at four different time intervals ie 1 hour,4 hour,12 hour,24 hour following extubation.Point 0 indicates no sore throat, 1 indicates a mild sore throat (complains only when questioned), 2 indicates a moderate sore throat (complains even when not questioned), and 3 indicates a severe sore throat (presence of hoarseness or voice change). Anybody with POST score of 3 or more will be treated with NSAIDS like Paracetamol and dexamethasone.They will not be excluded from the study.There will be a record of any adverse effects, such as vomiting, vertigo, metallic taste, or diarrhoea.
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