| CTRI Number |
CTRI/2024/08/072943 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
PreOp 50 Percent Magnesium Sulphate VS 2 Percent Plain Lignocaine Nebulization For Prevention Of Post Intubation Sore Throat |
|
Scientific Title of Study
|
A Comparison of Efficacy of Preoperative Nebulized Magnesium Sulphate (50 Percent) Versus Plain Lignocaine (2 Percent) For the Prevention of Postoperative Sore Throat in Patients Requiring Endotracheal Intubation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Suresh Balasubramanian |
| Designation |
Resident Doctor |
| Affiliation |
GMERS Medical College, Gandhinagar |
| Address |
1st Floor, New Civil Hospital Building, Department Of Anaesthesia, GMERS Medical College Gandhinagar
1st Floor, New Civil Hospital Building, Department Of Anaesthesia, GMERS Medical College Gandhinagar
Gandhinagar
GUJARAT
382012
India |
| Phone |
9725451012 |
| Fax |
|
| Email |
adisu.aditya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hina Gadani |
| Designation |
Associate Professor |
| Affiliation |
GMERS Medical College, Gandhinagar |
| Address |
1st Floor, New Civil Hospital Building, Department Of Anaesthesia, GMERS Medical College Gandhinagar
1st Floor, New Civil Hospital Building, Department Of Anaesthesia, GMERS Medical College Gandhinagar
Gandhinagar
GUJARAT
382012
India |
| Phone |
8690501339 |
| Fax |
|
| Email |
hinagadani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shobhana Gupta |
| Designation |
Professor and Head |
| Affiliation |
GMERS Medical College, Gandhinagar |
| Address |
GMERS Medical College,
Civil Hospital Campus,
Near Pathikasharam,
Sector - 12
Gandhinagar
GMERS Medical College,
Civil Hospital Campus,
Near Pathikasharam,
Sector - 12
Gandhinagar
Gandhinagar
GUJARAT
382012
India |
| Phone |
9978407067 |
| Fax |
|
| Email |
drshobhanagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College,
Civil Hospital Campus,
Near Pathikasharam,
Sector - 12
Gandhinagar - 382 012,
Gujarat,India |
|
|
Primary Sponsor
|
| Name |
GMERS Medical College Gandhinagar |
| Address |
GMERS Medical College
Civil Hospital Campus
Near Pathikasharam
Sector 12
Gandhinagar 382 012
Gujarat India |
| Type of Sponsor |
Government 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 Aditya Suresh Balasubramanian |
GMERS Medical College, Gandhinagar |
1st floor Department of Anaesthesia, New Civil Hospital Building, GMERS Medical College,
Civil Hospital Campus,
Near Pathikasharam,
Sector - 12
Gandhinagar - 382 012.
Gujarat
Gandhinagar
GUJARAT |
9725451012
adisu.aditya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMERS Medical College Gandhinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, (2) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (3) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (4) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (5) ICD-10 Condition: K810||Acute cholecystitis, (6) ICD-10 Condition: H604||Cholesteatoma of external ear, (7) ICD-10 Condition: H605||Acute noninfective otitis externa, (8) ICD-10 Condition: H650||Acute serous otitis media, (9) ICD-10 Condition: H664||Suppurative otitis media, unspecified, (10) ICD-10 Condition: H700||Acute mastoiditis, (11) ICD-10 Condition: H711||Cholesteatoma of tympanum, (12) ICD-10 Condition: H720||Central perforation of tympanic membrane, (13) ICD-10 Condition: H721||Attic perforation of tympanic membrane, (14) ICD-10 Condition: H673||Otitis media in diseases classified elsewhere, bilateral, (15) ICD-10 Condition: J019||Acute sinusitis, unspecified, (16) ICD-10 Condition: J039||Acute tonsillitis, unspecified, (17) ICD-10 Condition: H049||Disorder of lacrimal system, unspecified, (18) ICD-10 Condition: M462||Osteomyelitis of vertebra, (19) ICD-10 Condition: N200||Calculus of kidney, (20) ICD-10 Condition: N611||Abscess of the breast and nipple, (21) ICD-10 Condition: K929||Disease of digestive system, unspecified, (22) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulized Magnesium Sulphate (50%) |
0.5 ml of 250mg (50%) Nebulized Magnesium Sulphate + 3.5 ml Normal Saline will be given 20 minutes prior to induction of Anaesthesia for 15 minutes |
| Comparator Agent |
Nebulized Plain Lignocaine (2%) |
2 ml of 40mg (2%) Nebulized Plain Lignocaine + 2 ml Normal Saline will be given 20 minutes prior to induction of Anaesthesia for 15 minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II
Mallampati Grade I and II
Age :18-50 years
Weight: 50-80 kg
Both Male and Female Genders
Patients undergoing surgery with duration ranging from 1-3 hrs under general anaesthesia with tracheal intubation
|
|
| ExclusionCriteria |
| Details |
Patient refusal for Nebulization
Patients undergoing Head and Neck Surgeries
Patients with a history of preoperative sore throat or any respiratory disease
Pregnant/Lactating females
Patients allergic to the study drugs
Patients with compromised renal function, cardiac diseases and neuromuscular disease.
Patients with NasoGastric tube or any nasal or throat packs or who require these intraoperatively.
Patients with anticipated difficult intubation.
Patients requiring laryngoscopy and intubation for over 30 seconds or necessitating more than one attempt for intubation.
Patients requiring the chronic use of steroids and/or the use of NSAIDS
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of Postoperative Sore Throat (POST) among patients receiving nebulized magnesium sulphate (50%) and those receiving nebulized plain lignocaine (2%) requiring endotracheal intubation. |
The incidence and severity of At 0 h (on arrival to post-anesthesia care unit (PACU)), 2, 4, 6, 8, 12 and 24 h postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the occurrence of any side effects Eg. Nausea/Vomiting, skin rash, dry mouth, hypotension, bradycardia and cough etc.
|
in the first 24hrs post nebulization |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
02/09/2024 |
| 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
|
General anaesthesia plays a crucial role in the field of anaesthesia, with endotracheal intubation being a vital measure to safeguard the airway. Postoperative sore throat, hoarseness of voice, and cough often follow endotracheal intubation. Postoperative sore throat (POST) stands out as a frequent consequence of endotracheal intubation lasting for about 12-24 hrs after surgery, with reported prevalence ranging from 18 to 65%. Various pharmacological and non-pharmacological methods have been employed to manage postoperative sore throat following general anaesthesia. Pharmacological methods like Nebulization with beclomethasone and Fluticasone, gargling with azulene sulfonate, aspirin, ketamine, lignocaine and magnesium, benzydamine, green tea, hydrochloride and licorice and local spray of benzydamine hydrochloride, lignocaine with varying degrees of effectiveness. Few studies have been published on efficacy of preoperative nebulised ketamine, magnesium sulphate, lignocaine and normal saline on postoperative sore throat, but very few comparing the efficacy of Magnesium sulphate and Lignocaine on postoperative sore throat. The data being collected from this study will be used to establish a standardised preoperative protocol which could be applicable in our institute and other healthcare settings further being beneficial to the patients |