| CTRI Number |
CTRI/2025/03/082734 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of lignocaine jelly versus betamethasone gel on endotracheal tubes in reducing postoperative sore throat,cough and hoarseness of voice. |
|
Scientific Title of Study
|
Comparison between lignocaine jelly versus betamethasone gel applied over endotracheal tube to reduce postoperative sore throat,cough and hoarseness of voice. |
| 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 Rajlakshmi |
| Designation |
Resident doctor (M.D Anaesthesiology) |
| Affiliation |
BJ Medical college Ahmedabad |
| Address |
F-3 Department of Anaesthesiology, B.J. Medical college civil hospital, Asarwa Ahmedabad. Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
8002969448 |
| Fax |
|
| Email |
priya.rajlakshmi631@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Vansola |
| Designation |
Assistant Professor(MD Anaesthesiology) |
| Affiliation |
BJ Medical college Ahmedabad |
| Address |
F3, Department of Anaesthesiology, Civil Hospital, B.J. Medical College Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9099952630 |
| Fax |
|
| Email |
reema.vansola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reema Vansola |
| Designation |
Assistant Professor(MD Anaesthesiology) |
| Affiliation |
BJ Medical college Ahmedabad |
| Address |
F3, Department of Anaesthesiology, Civil Hospital, B.J. Medical College Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9099952630 |
| Fax |
|
| Email |
reema.vansola@gmail.com |
|
|
Source of Monetary or Material Support
|
| F-3, Dept of Anaesthesia, B.J Medical college and civil hospital Asarwa Ahmedabad Gujrat, India - 380016. |
|
|
Primary Sponsor
|
| Name |
Dr Rajlakshmi |
| Address |
Room. A-403 Phase-1, New PG Hostel, Asarwa Civil Hospital Ahmedabad, Gujarat, India - 380016 |
| Type of Sponsor |
Other [self] |
|
|
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 Rajlakshmi |
B.J Medical College and Civil Hospital |
F-3, Department of Anaesthesiology
Ahmadabad
GUJARAT |
08002969448
priya.rajlakshmi631@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B.J Medical College and 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.05% betamethasone gel |
Dose- 0.05% betamethasone gel 1-2ml, as a lubricant applied over endotracheal tube cuff once before intubation. |
| Comparator Agent |
2% lignocaine jelly |
Dose-2% lignocaine jelly 1-2ml as a lubricant applied over endotracheal tube cuff once before intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I, II, III
2. Elective procedures requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1. ASA grade IV & V
2. Patient with history of adverse drug reaction to study medications
3. Pregnant and lactating women
4. Patients having upper respiratory tract infections and oronasal surgeries
5. Anticipated difficult airway
6. Vocal cord pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative sore throat, cough and hoarseness of voice after endotracheal intubation. |
Immediately after extubation, 1 hours,4 hours, 6 hours,12 hours, 24 hours, 36 hours, and 48 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the hemodynamic response |
For 2 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="0"
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
|
Many of the general anaesthetic procedures in the modern anaesthesia practices are carried out with endotracheal intubation. It has advantages including the provision of the reliable airway, prevention of aspiration and smooth delivery of anaesthetic gases. All patients who were intubated for long duration or short duration operations had some degree of airway injury. Common adverse effects of cuffed endotracheal tube-like local irritation, inflammation of the airway mucosa etc leads to post-extubation morbidities such as sore throat, cough and hoarseness of voice which is extremely distressing to the patient. This study will be done to compare the efficacy of betamethasone gel and lignocaine jelly as lubricants in reducing post-operative sore throat, cough and hoarseness of voice in patients operated under general anaesthesia with endotracheal intubation.
|