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CTRI Number  CTRI/2025/12/099825 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Dexmedetomidine, Lignocaine, and Air Used to Inflate the Breathing Tube Balloon and Their Effect on Comfort During Removal After Anesthesia 
Scientific Title of Study   Comparison of Endotracheal Tube Cuff Inflation Between Dexmedetomidine, 2% Lignocaine and Air on Quality of Extubation: A Prospective Randomised Controlled Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrHema Shubha Yadlapalli  
Designation  Junior Resident  
Affiliation  Nizam’s Institute of Medical Sciences 
Address  Room No 8 , SPECIALITY BLOCK OT , 3rd Floor ,Department of Anaesthesia, Nizams Institute Of Medical Sciences, Punjagutta

Hyderabad
TELANGANA
500082
India 
Phone  9515347592  
Fax    
Email  hemashubha97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nirmala Jonnavithula 
Designation  Professor  
Affiliation  Nizam’s Institute of Medical Sciences 
Address  Room no 1, Speciality block OT, Department of Anaesthesia, 3rd floor,Nizam’s Institute of Medical Sciences,Punjagutta.

Hyderabad
TELANGANA
500082
India 
Phone  9849422749  
Fax    
Email  njonnavithula@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrHema Shubha Yadlapalli  
Designation  Junior Resident  
Affiliation  Nizam’s Institute of Medical Sciences 
Address  Room no 8, Speciality block OT, Department of Anaesthesia, 3rd floor,Nizam’s Institute of Medical Sciences,Punjagutta.

Hyderabad
TELANGANA
500082
India 
Phone  9515347592  
Fax    
Email  hemashubha97@gmail.com  
 
Source of Monetary or Material Support  
Nizams Institute of Medical Sciences, Punjagutta , Hyderabad - 500082 , India 
 
Primary Sponsor  
Name  Dr Hema Shubha Yadlapalli  
Address  Room No 8, SPECIALITY BLOCK OT , 3rd Floor ,Department of Anaesthesia, Nizams Institute Of Medical Sciences, Punjagutta , Hyderabad -500082 , India 
Type of Sponsor  Research institution and hospital 
 
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 Hema Shubha  Nizams Institue of Medical Sciences  Room No 8, SPECIALITY BLOCK OT , 3rd Floor ,Department of Anaesthesia, Nizams Institute Of Medical Sciences, Punjagutta , pincode 500082
Hyderabad
TELANGANA 
9515347592

hemashubha97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dm,HTN,CVA,CKD,CAD 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% lignocaine  endotracheal tube cuff inflated with 4-6 mL of 2%lignocaine at intubation and quality of extubation is assessed  
Comparator Agent  Air  endotracheal tube cuff inflated with 4-6ml of air at intubation and quality of extubation is assessed  
Intervention  Dexmedetomidine  Endotracheal tube cuff inflated with 1mcg/kg of Dexmedetomidine diluted to 4-6ml with normal saline at intubation and extubation quality is assessed  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Written and valid informed consent.
Estimated duration of surgery more than 60 min and less than 300 min.
ASA classes I and II
Body mass index (BMI) less than 30 kg/m2.
Elective surgeries
 
 
ExclusionCriteria 
Details  Patient refusal
ASA classes III and IV
Chronic smokers
laryngotracheal diseases/surgery
Known allergy to study agents
COPD, asthma, history of recent upper respiratory tract infection
Requiring insertion of nasogastric tube
Oro-pharyngeal airway introduced preoperatively
Multiple intubation attempts
Raised intracranial pressure, intraocular pressure
History of gastric regurgitation
Requiring rapid sequence induction
Anticipated difficult airway
Undergoing laparoscopic surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare post extubation cough response in different groups.  TE time at extubation
T1 1min after extubation
T2 2min after extubation
T5 5min after extubation
T10 10 min after extubation
T15 15 min after extubation
T30 30 min after extubation
T60 60 min after extubation
T2h 2h after extubation
T4h 4h after extubation
T6h 6h after extubation
T12h 12h after extubation
T24h 24h after extubation  
 
Secondary Outcome  
Outcome  TimePoints 
a)To assess and compare postoperative sore throat in different groups.
b) To assess and compare postoperative dysphagia in different groups.
c) To assess and compare postoperative hoarseness of voice in different groups.
d) To assess and compare peri-extubation hemodynamic parameters in different groups.
e) Likert scale for patient satisfaction on Post op day 1
 
TE time at extubation
T1 1min after extubation
T2 2min after extubation
T5 5min after extubation
T10 10 min after extubation
T15 15 min after extubation
T30 30 min after extubation
T60 60 min after extubation
T2h 2h after extubation
T4h 4h after extubation
T6h 6h after extubation
T12h 12h after extubation
T24h 24h after extubation  
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   30/12/2025 
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="0"
Months="6"
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  

Oral endotracheal intubation is a routine and indispensable component of general anesthesia management for surgical procedures. Cuffed tubes are preferred to uncuffed tubes as the inflated cuff offers a seal between the cuff and the trachea and enable positive pressure ventilation and prevent aspiration. The cuff pressure stimulates the stretch receptors in the tracheal mucosa causing  uncontrollable  postop cough and airway morbidities of sore throat, hoarseness, and dysphagia. Recently,  intracuff route is proven to be more efficacious  with prolonged duration than topical  route due to slow absorption into trachea bronchial mucosa. Dexmedetomidine , a novel  drug  is lipid soluble and has selective alpha 2 adrenergic agonistic action.It has gained popularity for its sedative and analgesic properties, and its potential anti-inflammatory effects. Regarding dexmedetomidine only topical and iv route trials have been conducted. There is still a lack of consensus in the literature regarding the  practice of  dexmedetomidine as intracuff route. Hence, we designed this study to evaluate intracuff dexmedetomidine with lignocaine on airway morbidities and haemodynamics  in patients under general anaesthesia.


 
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