| CTRI Number |
CTRI/2025/09/094760 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Study the Comparison of the Effects of Ketamine or Magnesium Sulphate Spray on the Incidence and Severity of Sore Throat Experienced after Surgery. |
|
Scientific Title of Study
|
A Randomised Clinical Trial Comparing the Impacts of Magnesium Sulphate and Ketamine Spray on the Incidence and Severity of Sore Throat following intubation in Patients Under General Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JENIN HERBERT |
| Designation |
Post Graduate Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department Of Aneasthesia
Christian Medical College
Department Of Aneasthesia
Christian Medical College
Vellore TAMIL NADU 632004 India |
| Phone |
9150522079 |
| Fax |
|
| Email |
jeninherbert@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
EKTA RAI |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department Of Aneasthesia
Christian Medical College
Department Of Aneasthesia
Christian Medical College
Vellore TAMIL NADU 632004 India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
EKTA RAI |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department Of Aneasthesia
Christian Medical College
Department Of Aneasthesia
Christian Medical College
Vellore TAMIL NADU 632004 India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
|
Source of Monetary or Material Support
|
| CHRISTIAN MEDICAL COLLEGE VELLORE |
|
|
Primary Sponsor
|
| Name |
CHRISTIAN MEDICAL COLLEGE |
| Address |
CHRISTIAN MEDICAL COLLEGE
VELLORE |
| Type of Sponsor |
Private 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 JENIN HERBERT |
CHRISTIAN MEDICAL COLLEGE HOSPITAL |
OPERATING ROOMS
DEPARTMENT OF ANESTHESIA
CHRISTIAN MEDICAL COLLEGE
Vellore TAMIL NADU |
09150522079
jeninherbert@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL REVIEW BOARD SILVER ETHICS AND RESEARCH COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, (2) ICD-10 Condition: N219||Calculus of lower urinary tract, unspecified, (3) ICD-10 Condition: C154||Malignant neoplasm of middle thirdof esophagus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ketamine |
Ketamine spray 0.5 mg/kg is administered using a Magik atomiser in the oral cavity at the uvula tonsils posterior pharyngeal wall vallecula and between vocal cords during laryngoscopy before intubation |
| Intervention |
magnesium sulphate |
magnesium spray 30MG PER KG is administered using a Magik atomiser in the oral cavity at the uvula tonsils posterior pharyngeal wall vallecula and between vocal cords during laryngoscopy before intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years to 60 years
2. Elective surgeries
3. ASA classes 1,2, and 3
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Allergic to the study drugs
3. Anticipated difficult airway
4. Emergency surgeries
5. Head and neck surgeries.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
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 ketamine spray in reducing the incidence and severity of postoperative sore throat. |
five time intervals: 30-minute,1,6,12, and 24 hours after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : To compare the effectiveness of magnesium and ketamine spray in reducing the incidence and severity of cough, dysphagia, and hoarseness |
five time intervals: 30 minutes, 1,6, 12, and 24 hours after extubation. |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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 1 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="1" 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
|
Post-operative sore throat refers to irritation or pain in the throat that occurs within 15 minutes to 24 hours after the extubation phase. The incidence of POST has been estimated to range from 6.6% to 90% following tracheal intubation, while the incidence is lower after LMA insertion (17.5%). POST is one of the major causes of patient dissatisfaction and discharge delays following ambulatory surgery. Routine tracheal intubation for elective surgical procedures can lead to pathological changes, trauma, and nerve damage, which may contribute to postoperative throat symptoms. Various medications, including ketamine, lidocaine, budesonide, dexamethasone, and magnesium sulphate, have been administered via nebulisation, gargling, or intravenous routes to alleviate this issue in different institutions. While numerous protocols have been proposed to prevent post-operative sore throat (POST), few have attracted significant interest. Various pharmacological and nonpharmacological methods have been explored to decrease POST incidence. Standard treatments include multimodal analgesia and adjuncts such as NSAIDs, lidocaine, and beclomethasone. Additionally, ketamine and magnesium sulphate gargles, as well as nebulization, have been tested, as these substances inhibit the N-methyl-D-aspartic acid receptor without providing direct analgesic effects. Research highlights the influence of factors like endotracheal tube size and cuff pressure on POST, yet literature on the effects of ketamine and magnesium sulphate aerosol is limited. This study aims to compare the impact of ketamine and magnesium sulphate atomizer spray on the occurrence of POST in adult patients undergoing general anaesthesia with endotracheal intubation. The study’s objective is to assess both the incidence of POST and the influence of these atomizer sprays on hemodynamic parameters. |