| CTRI Number |
CTRI/2025/12/099047 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see whether a steroid medicine inside the breathing tube reduces cough and sore throat after surgery. |
|
Scientific Title of Study
|
Comparison of intracuff Dexamethasone vs Normal saline for attenuation of post-extubation laryngotracheal morbidity. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutviksinh D Jadeja |
| Designation |
Resident doctor in department of anesthesiology |
| Affiliation |
B.J. Medical College & Civil Hospital. |
| Address |
Department of anesthesiology, F3, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9904387508 |
| Fax |
|
| Email |
rutviksinhjadeja1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shakuntala J Goswami |
| Designation |
Professor (H.G.) |
| Affiliation |
B.J. Medical College & Civil Hospital. |
| Address |
Department of anesthesiology, F3, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9327021192 |
| Fax |
|
| Email |
dhrumit09@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutviksinh D Jadeja |
| Designation |
Resident doctor in department of anesthesiology |
| Affiliation |
B.J. Medical College & Civil Hospital. |
| Address |
Department of anesthesiology, F3, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
09904387508 |
| Fax |
|
| Email |
rutviksinhjadeja1111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Gujarat, Health and Family welfare department, 7th floor, New sachivalaya, Gandhinagar. 382010 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
Health and Family welfare department 7th floor New sachivalaya Gandhinagar 382010 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 Rutviksinh D Jadeja |
BJ medical college and civil hospital |
MOT, 5th floor , trauma building and
gynecology OT, D1 wing,1200 bed,
Anesthesia department,
Ahmadabad
GUJARAT |
09904387508
rutviksinhjadeja1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, B.J. Medical Colleage & Civil hospital, Ahmedabad. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: J387||Other diseases of larynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intracuff Instillation of inj. Dexamethasone |
In laparoscopic surgery, intracuff Instillation of inj. Dexamethasone 0.2 mg/kg diluted in NS after intubation |
| Comparator Agent |
Intracuff Instillation of inj. Normal saline |
inj.NS Total volume given as per leak in the cuff of endotracheal tube after intubation and monitoring for outcome for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II, III
Mallampati I and II
Supine or trendelenberg position
Duration: 2 to 3 hours
Elective laparoscopic surgeries under GA with cuffed ETT
|
|
| ExclusionCriteria |
| Details |
Refusal to consent
ASA IV–V
Mallampati III–IV
Preexisting hoarseness, URI
Steroid use, COPD, Asthma
Known allergy to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare severity of Post extubation cough , sore throat and horseness |
1min, 5min, 10min, 15min, 30min, 60min, 6hours, 12hours, 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare post operative hemodynamic parameters |
Post operative 24 hours |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
26/12/2025 |
| 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="5"
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
|
Endotracheal intubation with cuffed tubes can cause laryngotracheal irritation and post-extubation symptoms such as cough, sore throat and hoarseness. Intracuff drug instillation may reduce these complications by reducing mucosal inflammation and preventing rise in cuff pressure. This randomized placebo-controlled clinical trial aims to compare the effectiveness of intracuff dexamethasone versus normal saline in reducing post-extubation airway morbidity in adult patients undergoing elective laparoscopic surgeries under general anaesthesia.
|