| 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
|
|
|
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
|
|
|
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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