CTRI

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CTRI Number

CTRI/2021/03/032191 [Registered on: 22/03/2021] Trial Registered Prospectively

Last Modified On:

14/09/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

A comparative study of two drugs, magnesium sulphate and budesonide in reducing the incidence and severity of post operative sore throat.

Scientific Title of Study

A comparative study of preoperative magnesium sulphate nebulisation and budesonide nebulisation in reducing the incidence and severity of post operative sore throat

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
179/2/PGT-2019 19/08/2019	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Laishram Rani Devi
Designation	Postgraduate Trainee
Affiliation	Jawaharlal Nehru Institute of Medical Sciences
Address	Department of Anaesthesiology Jawaharlal Nehru Institute of Medical Sciences Porompat-795005 Imphal East Thangal Bazar Near Post office Imphal-795001 Manipur Imphal West MANIPUR 795001 India
Phone	8617878542
Fax
Email	ranilaishram95@gmail.com

Details of Contact Person
Scientific Query

Name	Ibemhal Heisnam
Designation	Associate Professor
Affiliation	Jawaharlal Nehru Institute of Medical Sciences
Address	Department of Anaesthesiology Jawaharlal Nehru Institute of Medical Sciences Porompat-795005 Imphal Imphal East MANIPUR 795005 India
Phone	7628898198
Fax
Email	dribemhal@gmail.com

Details of Contact Person
Public Query

Name	Laishram Rani Devi
Designation	Postgraduate Trainee
Affiliation	Jawaharlal Nehru Institute of Medical Sciences
Address	Department of Anaesthesiology Jawaharlal Nehru Institute of Medical Sciences Porompat-795005 Imphal Thangal Bazar Near Post Office Imphal-795001 Manipur Imphal West MANIPUR 795001 India
Phone	8617878542
Fax
Email	ranilaishram95@gmail.com

Source of Monetary or Material Support

Institutional Jawaharlal Nehru Institute of Medical Sciences Porompat-795005 Manipur

Primary Sponsor

Name	Laishram Rani Devi
Address	C/o Dr. L M Singh Thangal Bazar Near Post Office Imphal-795001 Manipur
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Laishram Rani Devi	Jawaharlal Nehru Institute of Medical Sciences	Department of Anaesthesiology JNIMS Porompat-795005 Imphal Imphal East MANIPUR	8617878542 ranilaishram95@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, JNIMS	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	, (1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Budesonide	To assess the effectiveness of preoperative budesonide nebulisation in reducing the incidence and severity of post operative sore throat
Intervention	Magnesium sulphate	To assess the effectiveness of preoperative Magnesium sulphate nebulisation in reducing the incidence and severity of post operative sore throat
Comparator Agent	Normal saline	To assess the severity and incidence of postoperative sore throat

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patients who have signed written informed consent. Patients with ASA grade I-II Patients undergoing Elective surgery under general anaesthesia with endotracheal intubation. Patients undergoing surgery in supine position.

ExclusionCriteria

Details

Patient refusal.
History of known allergy to the drugs.
History of cough or Upper Respiratory Tract illness.
History of Respiratory diseases like COPD, Asthma etc.
History of smoking
Mallampati score >II
More than one attempt of intubation.
Patients undergoing oral or nasal surgeries.
Patients on long term anti-inflammatory analgesic medications.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
To compare the effectiveness of magnesium sulphate and budesonide in reducing the incidence and severity of post operative Sore throat	0hr, 2hrs, 24hrs and 48hrs after extubation

Secondary Outcome

Outcome	TimePoints
To assess the hemodynamic profile of the nebulised drugs and their acceptability score	Before and After nebulisation, Intraoperatively

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

Phase 4

Date of First Enrollment (India)

24/03/2021

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="10"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details

The study will be published in a peer reviewed journal once the study is completed.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

A double blinded, randomised control trial will be conducted in my Institution to compare the effectiveness of preoperative nebulisation of two drugs Magnesium sulphate and Budesonide in reducing the incidence and severity of Postoperative Sore Throat in patients undergoing elective surgery under general anaesthesia with endotracheal intubation.