| CTRI Number |
CTRI/2025/07/090479 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Application Of Betamethasone Gel and Lignocaine Gel on Endotracheal Tube to Reduce Post Operative Sore throat, Cough and Hoarseness of voice in Laproscopic Surgeries |
|
Scientific Title of Study
|
A Randomized Controlled Trial To Compare Application Of Betamethasone Gel And Lignocaine Gel On Endotracheal Tube To Reduce Post Operative Sore Throat, Cough And Hoarseness Of Voice In Laparoscopic Surgeries |
| 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 Nirali Panchal |
| Designation |
Professor |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical
College,Shree krishna Hospital,Karamsad,Anand,Gujarat.
Anand
GUJARAT
388325
India
Anand GUJARAT 388325 India |
| Phone |
9825031808 |
| Fax |
|
| Email |
niralipanchalnp@charutarhealth.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nirali Panchal |
| Designation |
Professor |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical
College,Shree krishna Hospital,Karamsad,Anand,Gujarat.
Anand
GUJARAT
388325
India
Anand GUJARAT 388325 India |
| Phone |
9825031808 |
| Fax |
|
| Email |
niralipanchalnp@charutarhealth.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Aditya Patel |
| Designation |
Resident |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka University |
| Address |
Department of Anesthesiology,Pramukh Swami Medical
College,Shree krishna Hospital,Karamsad,Anand,Gujarat.
Anand
GUJARAT
388325
India
Anand GUJARAT 388325 India |
| Phone |
8799197228 |
| Fax |
|
| Email |
adipatel247@gmail,com |
|
|
Source of Monetary or Material Support
|
| Shree Krishna Hospital,Prumukhswami Medical college, karamsad ,anand |
|
|
Primary Sponsor
|
| Name |
Shree Krishna Hospital |
| Address |
Shree Krishna Hospital,Karamsad,Anand,Gujarat,India.388325 |
| Type of Sponsor |
Private 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 Nirali Panchal |
Pramukh Swami medical college,shree Krishna Hospital,Karam sad,Anand |
Department of
Anesthesiology,Surgical
operation theater
complex
Anand
GUJARAT Anand GUJARAT |
9825031808
dr.niralipanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaikaka University, Karamsad, Anand, Gujrat, 388325. |
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 |
Application of Betamethasone gel on endotracheal tube in laproscopic surgeries |
Application of Betamethasone gel on endotracheal tube in laproscopic surgeries to reduce post operative sore throat, cough, and hoarseness of voice in laparoscopic surgeries |
| Comparator Agent |
Application of Lignocaine gel on endotracheal tube in laproscopic surgeries |
Application of Lignocaine gel on endotracheal tube in laproscopic surgeries to reduce post operative sore throat, cough, and hoarseness of voice in laparoscopic surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA(American Society of Anaesthesiologists) physical status I,II,III
Patients able to provide informed consent
Patients with a normal airway anatomy
Patients not taking medications that may interact with betamethasone or lidocaine
|
|
| ExclusionCriteria |
| Details |
Patient who will not give consent
More than two attempts at intubation
Patients with URTI
Patients with a predicted difficult airway
Patients on steroid therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of Post-Operative Sore Throat in betamethasone gel and lignocaine jelly, applied topically over the tracheal tube |
Post-Operative Sore Throat |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of Cough post extubation |
Immediate post extubation |
| Incidence and severity of hoarseness of voice |
At 1,6,12,24 hrs after extubation |
| Incidence and severity of postoperative sore throat |
At 1,6,12,24 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="82" Sample Size from India="82"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/07/2025 |
| 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="0" 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
|
After obtaining institutional ethics committee approval and
written and informed consent from patients of ASA I to III who will be
undergoing surgery under general anaesthesia with endotracheal intubation will
be included in this study. Preanesthetic check-up will be carried out in all
patients. The patients will be divided into two groups. In Group
B—where patients were intubated with endotracheal tube lubricated with 0.05%
betamethasone gel; group L—endotracheal tube lubricated with 2% lidocaine jelly. Patients will be kept Nil by mouth (NBM) for 8 hours for
solids and 2 hrs for clear liquid before surgery with required medication
before surgery Appropriate fluids will be started in preoperative room and will
be continued in the operation theatre (OT). After the patient is taken in the
operating room, monitors like Pulse oximetry, electrocardiogram, non-invasive
blood pressure monitoring, manual blood pressure monitoring and end tidal carbon dioxide monitoring device
will be applied and hemodynamic variables will be measured on arrival to the OT
and every 5 min thereafter till the end of surgery. Standard anaesthesia technique for induction of general
anaesthesia will be used. Patients will be premedicated with injection
midazolam 0.02 mg/kg, fentanyl 2 mcg/kg, Lignocaine 2 % (preservative free) 1.5
mg/kg as per protocol. Patients will be induced with IV induction agents and
with muscle relaxation as per the case. General anaesthesia will be given by
Endotracheal Tube. Before intubation, the endotracheal tube was lubricated from
the distal end of the cuff to a distance of 15 cm from the tip using 2.5 ml of
0.05% betamethasone dipropionate gel for patients in group B and with 2.5 ml 2%
lidocaine jelly for patients in group L. Immediately after intubation and
confirmation of the tube position, the tracheal tube cuff was inflated with
room air to keep the intracuff pressure between 18 and 25 mmHg, measured
using a tracheal cuff pressure manometer Anaesthesia will be maintained by O2, AIR and Sevoflurane/
Desflurane. End-tidal CO2 will be maintained between 35 and 40 mm of Hg. Pulse
rate, electrocardiogram, NIBP, and oxygen saturation will be monitored
continuously throughout the procedure. Before extubation as per the standard protocol adequate anti
emetic & analgesic will be given at the end of procedure. Inhale
anaesthetic gas will be discontinued. After achieving spontaneous respiration
efforts, neuromuscular blockade will be reversed with Inj. Neostigmine 0.05
mg/kg and Inj. Glycopyrrolate 0.01 mg/kg & patient will be extubated.
During this process of extubation patient’s responses will be noted. After
extubation, patients will be shifted to recovery room for further observation.
Post operative period will be defined from time of extubation till 24 hours. The
time of tracheal extubation will be noted and assessment of the patients for
the incidence and severity of POST, HOV and PEC will be done at 1, 6, 12 and 24
h after extubation. |