CTRI

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CTRI Number

CTRI/2023/11/060143 [Registered on: 22/11/2023] Trial Registered Prospectively

Last Modified On:

21/11/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia
Preventive

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

To compare the effectiveness of preoperative nebulisation with budesonide and saline in reducing the incidence of post operative sore throat

Scientific Title of Study

Comparison of preoperative budesonide and saline nebulisation in reducing the incidence of postoperative sore throat in patients undergoing general anaesthesia with endotracheal intubation-A randomised controlled trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Sanjay M R
Designation	Post graduate resident,Department of anaesthesiology
Affiliation	Malankara Orthodox Syrian Church Medical College
Address	Post graduate resident Department of anaesthesiology MOSC Medical college Kolenchery Ernakulam KERALA 682311 India
Phone	9605490043
Fax
Email	sanju230593@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sunitha K Zachariah
Designation	Associate Professor
Affiliation	Malankara Orthodox Syrian Church Medical College
Address	Department of anaesthesiology Malankara Orthodox Syrian Church Medical college Kolenchery Ernakulam KERALA 682311 India
Phone	9656277614
Fax
Email	sunutg97@yahoo.co.in

Details of Contact Person
Public Query

Name	Sanjay M R
Designation	Post graduate resident,Department of anaesthesiology
Affiliation	Malankara Orthodox Syrian Church Medical College
Address	Post graduate resident Department of anaesthesiology MOSC Medical college Kolenchery KERALA 682311 India
Phone	9605490043
Fax
Email	sanju230593@gmail.com

Source of Monetary or Material Support

Malankara Orthodox Syrian Church Medical College

Primary Sponsor

Name	MOSC Medical College
Address	MOSC Medical College Kolenchery Ernakulam
Type of Sponsor	Private medical college

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
Dr Sanjay M R	Malankara Orthodox Syrian Church Medical College Hospital,Kolenchery	Department of anaesthesiology Malankara Orthodox Syrian Church Medical College Kolenchery(p.o) kolenchery Ernakulam KERALA	9605490043 sanju230593@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IEC Malankara Orthodox Syrian Church Medical College,Kolenchery	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Post operative sore throat,hoarseness of voice,cough in patients undergoing general anaesthesia with endotracheal intubation

Intervention / Comparator Agent

Type	Name	Details
Intervention	Budesonide	Preoperative nebulisation with budesonide 1ml(250mcg) with 4ml saline 15minutes prior to the induction of anaesthesia
Comparator Agent	Normal saline	Preoperative nebulisation with normal saline 5ml 15minutes prior to the induction of anaesthesia

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Age 20-60 years ASA 1-2 Patients undergoing elective surgery under general anaesthesia with endotracheal intubation surgeries of duration 1-6hours

ExclusionCriteria

Details

Patients with preexisting sore throat,URTI,COPD,Asthma
Mallampati score>2
Patients undergoing oral/nasal surgeries,thyroidectomy
Patients requiring more than one attempt at 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
Incidence of post operative sore throat	0,2,4,24hrs

Secondary Outcome

Outcome	TimePoints
Severity of post operartive sore throat,incidence of cough,incidence of hoarsness of voice	0,2,4,24hours

Target Sample Size

Total Sample Size="96"
Sample Size from India="96"
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)

30/11/2023

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

30/11/2023

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
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

This study is to compare the effectivenss of nebulisation budesonide to that of saline in reducing the incidence of Postoperative sore throat (POST)

A Randomised controlled trial will be conducted over a period of 1 year and 6 months on 96 patients of ASA I-II status,in the age group 20-60 years undergoing elective surgery requiring GA with endotracheal intubation.All patients will be subjected to a thorough pre anaesthetic evaluation, the study will be explained in detail and written informed consent will be obtained.

Patients enrolled for study will be randomised into two groups of 48 each,using computer generated random number tables in opaque sealed envelopes.The envelopes will be opened by a circulating nurse not involved in the study. Preoperative nebulisation will be given to the groups 15 minutes prior to the induction of anaesthesia as follows

Group B-Neb.Budesonide 1ml(250 mcg)

with 4ml normal saline(5ml)

Group S-Neb.Normal saline (5ml)

Patient will be induced with Injection Fentanyl 1-2 mcg/kg body weight, Propofol 1.5-2mg/kg and Rocuronium 1mg/kg. Direct laryngoscopy and tracheal intubation will be done with a sterile soft seal polyvinylchloride cuffed endotracheal tube. The tracheal cuff pressure will be maintained between 20-25cm of H2O. Anaesthesia will be maintained with oxygen, air and sevoflurane.

On completion of surgery, patients will be extubated and transferred to PACU. Incidence and severity of sore throat,incidence of cough and hoarsenss of voice will be assessed based on the scales provided in table 1 of the annexure at 0hr, 2hrs,4hrs,24hrs. Data will be summarised by using descriptive statistics.