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CTRI Number  CTRI/2025/12/099094 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective comparative study 
Study Design  Other 
Public Title of Study   study of endotracheal cuff inflation with 2% alkalinised lignocaine for preventing Post-Operative Sore Throat (POST) and reducing emergence phenomena after tracheal extubation in adult patients undergoing general anaesthesia 
Scientific Title of Study   A comparative study of endotracheal cuff inflation with 2 percentage alkalinised lignocaine vs air for preventing Post-Operative Sore Throat (POST) and reducing emergence phenomena after tracheal extubation in adult patients undergoing general anaesthesia 
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 Diya Jolly 
Designation  Junior Resident 
Affiliation  Sree Uthradom Thirunal Academy of Medical Sciences, Thiruvananthapuram 
Address  Department of Anesthesiology, Sree Uthradom Thirunal Academy of medical sciences

Thiruvananthapuram
KERALA
685029
India 
Phone  09446036494  
Fax    
Email  diyamaryjolly@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Annet Susan Abraham  
Designation  Assisstant Professor 
Affiliation  Sree Uthradom Thirunal Academy of Medical Sciences, Thiruvananthapuram 
Address  Department of Anaesthesiology, Sree Uthradom Thirunal Academy of Medical Sciences, Vattapara, Thiruvananthapuram

Thiruvananthapuram
KERALA
695028
India 
Phone  7907576437  
Fax    
Email  annetabraham92@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Annet Susan Abraham 
Designation  Assisstant Professor 
Affiliation  Sree Uthradom Thirunal Academy of Medical Sciences, Thiruvananthapuram 
Address  Department of Anaesthesiology, Sree Uthradom Thirunal Academy of Medical Sciences, Vattapara, Thiruvananthapuram

Thiruvananthapuram
KERALA
695028
India 
Phone  7907576437  
Fax    
Email  annetabraham92@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Sree Uthradom Thirunal Academy of Medical Sciences, Thiruvananthapuram. Pin code– 695028 
 
Primary Sponsor  
Name  Self myself 
Address  Sree Uthradom Academy Of Medical Sciences, Vencode, Vattapara, Kerala 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Annet Susan Abraham  SUT Hospital  Department of Anaesthesiology, Sree Uthradom Thirunal Academy of Medical Sciences, Vattapara, Thiruvananthapuram
Thiruvananthapuram
KERALA 		 07907576437

annetabraham92@gmail.com 
Dr Diya Jolly  SUT Hospital  SUT Academy of Medical Sciences, Vencod, Vattappara, Venkode, Kerala 695028
Thiruvananthapuram
KERALA 		 09446036494

diyamaryjolly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M16||Osteoarthritis of hip, (2) ICD-10 Condition: N30-N39||Other diseases of the urinary system, (3) ICD-10 Condition: K00-K95||Diseases of the digestive system, (4) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adult patients undergoing elective surgery under general anaesthesia requiring cuffed endotracheal tube
ASA1 ASA2 ASA3 
 
ExclusionCriteria 
Details  Pregnancy.
Allergy to local anaesthetics
Those who are not willing for study
Terminally ill patients
Paediatric population 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HR,BP,MAP, Post op sore throat, post op nausea and vomiting  1.Heart rate, BP, MAP will be recorded prior to extubation, immediately following extubation, and after the patient is shifted to the postoperative ICU.
2.Just after extubation, patients will be assessed for the incidence of cough postoperatively using the Minogue Cough Score and reassessed again at 1 hr, 6 hr, and 12 hr post-extubation of trachea.
Will be assessed for postoperative sore throat (POST) using a sore throat score at 1 hr, 6 hrs, and 12hr
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of postoperative cough following inflation of the
endotracheal tube cuff with 2% alkalinised lidocaine versus air 		 1st hour, 6th hour & 12th hour 
To assess postoperative emergence by comparing hemodynamic changes,
including heart rate, blood pressure, & mean arterial pressure, after
extubation in patients whose endotracheal tube cuffs were inflated with 2%
alkalinised lignocaine versus air. 		 Prior to extubation, immediately after extubation & after shifted to postop ICU 
To compare the incidence of postoperative nausea & vomiting between
patients whose endotracheal tube cuffs are inflated with 2% alkalinised
lignocaine & those inflated with air 		 After 12 hours 
To assess patient satisfaction 12 hours after surgery under general
anaesthesia, comparing patients whose endotracheal tube cuffs were
inflated with 2% alkalinised lignocaine versus air. 		 after 12 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/12/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [diyamaryjolly@gmail.com].

  6. For how long will this data be available start date provided 30-09-2025 and end date provided 30-09-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   All patients will undergo preoperative evaluation and receive standardized premedication. General anaesthesia will be induced with propofol and vecuronium, followed by tracheal intubation using a cuffed endotracheal tube. Depending on group allocation, the cuff will be inflated either with alkalinised 2% lignocaine or with air. Anaesthesia will be maintained with oxygen, air, and sevoflurane under controlled ventilation. Standard monitoring and intraoperative cuff pressure measurements will be performed throughout surgery. At the end, neuromuscular blockade will be reversed, and extubation carried out after suctioning. Postoperatively, patients will be monitored for hemodynamic changes, cough, sore throat, and nausea or vomiting for 12 hours. 
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