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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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