| CTRI Number |
CTRI/2025/11/098025 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study comparing two throat sprays used during general anaesthesia to see which better prevents cough, sore throat, and hoarseness after surgery. |
|
Scientific Title of Study
|
A clinical study of comparative evaluation of effect of benzydamine hydrochloride (0.15 percent) spray and lidocaine hydrochloride (10 percent) spray on endotracheal tube cuff on post-operative cough, sore throat and hoarseness of voice in patients undergoing general anaesthesia with endotracheal tube placement. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshit Jindal |
| Designation |
Junior Resident |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesiology & Critical Care, Subharti Medical College, NH-58, Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Department of Anaesthesiology & Critical Care, Subharti Medical College, NH-58, Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9996120088 |
| Fax |
|
| Email |
dr.jindalharshit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivek Maratha |
| Designation |
Professor |
| Affiliation |
SUBHARTI MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology & Critical Care, Subharti Medical College, NH-58, Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Department of Anaesthesiology & Critical Care, Subharti Medical College, NH-58, Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9837035415 |
| Fax |
|
| Email |
drvivekmaratha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Maratha |
| Designation |
Professor |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesiology & Critical Care, Subharti Medical College, NH-58, Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Department of Anaesthesiology & Critical Care, Subharti Medical College, NH-58, Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9837035415 |
| Fax |
|
| Email |
drvivekmaratha@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shivaji Subharti Hospital, Subharti Medical College, Meerut-250005, Uttar Pradesh (India) |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Harshit Jindal |
Chhatrapati Shivaji Subharti Hospital, Swami Vivekanand Subharti University |
Department of Anaesthesiology & Critical Care, Subharti Medical College, NH-58, Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH |
9996120088
dr.jindalharshit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
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 |
Benzydamine hydrochloride (0.15%) spray |
2 years. The study drug will be applied as two puffs directly to the endotracheal tube (ETT) cuff before induction of general anaesthesia. |
| Comparator Agent |
Lidocaine hydrochloride (10%) spray |
2 years. The study drug will be applied as two puffs directly to the endotracheal tube (ETT) cuff before induction of general anaesthesia. |
| Comparator Agent |
Normal saline spray |
2 years. The study drug will be applied as two puffs directly to the endotracheal tube (ETT) cuff before induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 65 years
2. Patients of either gender
3. ASA physical status I-IV |
|
| ExclusionCriteria |
| Details |
1. Pre-existing airway disorders such as chronic cough, recurrent sore throat, or chronic respiratory conditions including asthma or chronic obstructive pulmonary disease (COPD).
2. Known allergy to study drugs.
3. Anticipated difficult airway.
4. Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The incidence of postoperative sore throat, hoarseness of voice, and cough at predetermined postoperative time intervals(0,1,6,12,24 hours) after extubation, compared among patients receiving benzydamine hydrochloride (0.15%), lidocaine hydrochloride (10%), or normal saline spray applied to the endotracheal tube cuff. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of side effects (if any) associated with benzydamine hydrochloride (0.15%) and lidocaine hydrochloride (10%) sprays applied to the endotracheal tube cuff. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="432"
Sample Size from India="432"
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)
|
25/11/2025 |
| 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="2"
Months="0"
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 a randomized controlled study comparing the effectiveness of benzydamine hydrochloride (0.15%) spray, lidocaine hydrochloride (10%) spray, and normal saline spray when applioed to the endotracheal tube (ETT) cuff in reducing the incidence of postoperative cough, sore throat, and hoarseness of voice in patients undergoing general anaesthesia with endotracheal intubation. The primary objective is to compare the incidence of postoperative sore throat, hoarseness of voice, and cough among patients undergoing general anaesthesia following the application of either benzydamine hydrochloride, lidocaine hydrochloride, or normal saline spray on the endotracheal tube cuff. The secondary objective is to evaluate side effect (if any) of benzydamine hydrochloride and lidocaine hydrochloride. |