| CTRI Number |
CTRI/2025/10/096068 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out which medicine - lignocaine or budesonide nebulisation given before surgery, better helps to prevent sore throat in adults after using an airway device during anaesthesia.
|
|
Scientific Title of Study
|
Comparison of preoperative nebulisation with Lignocaine versus Budesonide for prevention of Post Operative Sore Throat after Supraglottic Airway insertion in adult patients undergoing 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 |
Mounica L |
| Designation |
PG Resident |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
Department of Anaesthesia,
ABVIMS and Dr.RML Hospital,
Baba Kharak Singh Road,
Connaught Place,
New Delhi-110001,
India.
New Delhi
DELHI
110001
India |
| Phone |
8076418351 |
| Fax |
|
| Email |
mounica1512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tina Khurana |
| Designation |
Associate Professor |
| Affiliation |
ABVIMS and Dr.RML Hospital, |
| Address |
Department of Anaesthesia, ABVIMS and Dr.RML Hospital,
Baba Kharak Singh Road,
Connaught Place,
New Delhi-110001,
India.
New Delhi
DELHI
110001
India |
| Phone |
9810617583 |
| Fax |
|
| Email |
tina.khurana1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tina Khurana |
| Designation |
Associate Professor |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
Department of Anaesthesia, ABVIMS and Dr.RML Hospital,
Baba Kharak Singh Road,
Connaught Place,
New Delhi-110001,
India.
New Delhi
DELHI
110001
India |
| Phone |
9810617583 |
| Fax |
|
| Email |
tina.khurana1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, ABVIMS and Dr.RML Hospital,
Baba Kharak Singh Road,
Connaught Place,
New Delhi-110001,
India. |
|
|
Primary Sponsor
|
| Name |
ABVIMS AND DRRML HOSPITAL |
| Address |
Department of Anaesthesia,
ABVIMS AND DR.RML HOSPITAL,
Baba Kharak Singh Road,
Connaught Place,
New Delhi-110001,
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 |
| Tina Khurana |
ABVIMS and Dr.RML Hospital |
302,Department of Anaesthesia, ABVIMS and Dr.RML Hospital,
Baba Kharak Singh Road,
Connaught Place,
New Delhi-110001,
India.
New Delhi
DELHI |
9810617583
tina.khurana1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ABVIMS AND DR.RML HOSPITAL |
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 |
Budesonide |
Preoperative nebulisation with Budesonide 500mcg diluted to 5ml by adding 0.9% normal saline.
Patients will be given this nebulisation once, 10 minutes before the induction of anaesthesia. |
| Intervention |
Lignocaine 4% |
Preoperative nebulisation with 2 ml of Lignocaine 4% diluted to 5ml by adding 0.9% normal saline.
Patients will be given this nebulisation once, 10 minutes before the induction of anaesthesia. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with BMI less than 30kg/m²;
ASA I and II patients;
Patients posted for elective surgery of 2-3 hours duration requiring supraglottic airway insertion under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient with allergy to the study drugs;
Patients with upper respiratory tract infections within the last two weeks; Patients with anticipated difficult airway; Patients with history of asthma, COPD or any other respiratory illness; Patients requiring more than 2 attempts at SGA insertion or alternative SGA placement or endotracheal intubation; Patients with history of recent steroid use; Patients undergoing surgery of more than 3 hours duration |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of Post Operative Sore Throat using POST scale |
1hour, 2hours, 4hours, 6hours and 24 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence & severity of dysphagia using NRS |
6hours & 24 hours post operatively |
| Incidence & severity of Cough using Cough Symptom Score |
1hour, 2hours, 4hours, 6 hours & 24hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
26/10/2025 |
| 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="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 is a randomised comparative study to compare the effect of preoperative nebulisation with Lignocaine versus Budesonide for prevention of Post Operative Sore Throat after supraglottic airway inserion in adult patients undergoing General Anaesthesia. Total sample size - 86 (43 patients in neach group)
Primary Objective is to compare preoperative nebulisation with Lignocaine versus Budesonide for prevention of post operative sore throat after supraglottic airway insertion in adult patients undergoing general anaesthesia.
Secondary Objective is 1. To compare preoperative nebulisation with Lignocaine versus Budesonide for prevention of post operative dysphagia after supraglottic airway insertion in adult patients undergoing general anaesthesia. 2. To compare preoperative nebulisation with Lignocaine versus Budesonide for prevention of post operative cough after supraglottic airway insertion in adult patients undergoing general anaesthesia. |