| CTRI Number |
CTRI/2025/10/096357 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of preoperative nebulisation with Magnesium Sulphate and ketamine for prevention of postoperative Sore Throat After Endotracheal Intubation in a Tertiary care Centre |
|
Scientific Title of Study
|
Comparison of preoperative nebulisation with Magnesium Sulphate and ketamine for prevention of postoperative Sore Throat After Endotracheal Intubation in a Tertiary care Centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVenkatesh Soundarya |
| Designation |
PG student |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Sapthagiri Institute Of Medical Sciences And Research Centre,Hesarghatta main road,Chikkabanavara, Bangalore 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
8668024382 |
| Fax |
|
| Email |
ssoundaryav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashanth Prabhu J |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
15,Hesaraghatta road,Navy layout,Sapthagiri Institute Of Medical Sciences And Research Centre
Room number : Ot 1,2and 3
Division : Anaesthesiology
Department of Anaesthesiology
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashanth Prabhu J |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
15,Hesaraghatta road,Navy layout,Sapthagiri Institute Of Medical Sciences And Research Centre
Room number : Ot 1,2and 3
Division : Anaesthesiology
Department of Anaesthesiology
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute Of Medical Sciences And Research Centre, Bangalore 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
15,Hesaraghatta road,Navy layout,Sapthagiri Institute Of Medical Sciences And Research Centre,Bangalore
560090
Karnataka
|
| 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 |
| DrVenkatesh Soundarya |
Sapthagiri Institute Of Medical Sciences And Research Centre |
15,Hesaraghatta road,Navy layout,Sapthagiri Institute Of Medical Sciences And Research Centre
Room number : Ot 1,2and 3
Division : Anaesthesiology
Department of Anaesthesiology
Bangalore
KARNATAKA |
08668024382
ssoundaryav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute Of Medical Sciences And Research Centre Institutional Ethics Committee |
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 |
Ketamine nebulisation |
Ketamine nebulisation with 50 mg preoperative |
| Comparator Agent |
Magnesium Sulphate |
Magnesium Sulphate nebulisation 500 mg preoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 and 2
2.General anaesthesia requiring Endotracheal intubation
3.Informed consent |
|
| ExclusionCriteria |
| Details |
Existing sore throat
Hypersensitivy to study drug
Oral surgeries
BMI greater than 30
Pregnant and lactating women
Patients with upper respiratory tract symptoms |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of ketamine nebulisation and magnesium sulphate nebulisation to decrease incidence of postoperative sore throat in patients undergoing endotracheal intubation |
Baseline,2hrs,4 hrs,6 hrs,12 hrs,24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="0"
Months="5"
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 - NO
|
|
Brief Summary
|
Modern Anaesthesia is safe, balanced and of utmost importance to improve surgical outcome So it is essential to decrease the incidence and severity of anaesthesia related complications. The incidence of post operative sore throat is about 21-65%. It is still a major complaint as there are various causative factors of post operative sore throat like erosion and inflammation due to endotracheal intubation, mucosal trauma, lack of airway humidity, suctioning of airway. So, all efforts are made to decrease post operative sore throat in patients undergoing general anaesthesia with endotracheal intubation. There are various non pharmacological and pharmacological methods used to decrease post operative sore throat. Non pharmacological methods include smaller size endotracheal tube, lubrication of endotracheal tube with water-soluble jelly, careful airway instrumentation, intubation after full relaxation, pharyngeal and oral suction, minimal intracuff pressure and extubation after fully deflating tracheal cuff. Pharmacological methods to decrease post operative sore throat includes inhalation of steroids like beclomethasone and fluticasone, gargling with azuline sulphate, aspirin, ketamine, nebulization with magnesium sulphate, ketamine, lignocaine and intracuff administration of alkalized lignocaine The study is conducted to compare the incidence of post operative sore throat using ketamine and magnesium sulfate nebulization in patients who will be undergoing endotracheal intubation
|