| CTRI Number |
CTRI/2025/07/091424 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Dexmedetomidine with lignocaine to check post-extubation cough reflex |
|
Scientific Title of Study
|
Supra and subglottic instillation of dexmedetomidine for prevention of coughing during emergence from general anaesthesia : A comparison with lignocaine .
|
| 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 HARSHA |
| Designation |
Junior Resident |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Ward Block 13, NEAR Neuro OT Complex, First floor, Department of Anaesthesiology, Indira Gandhi Institute Of Medical Sciences, , Sheikhpura, Patna, Bihar, India
Indira Gandhi Institute Of Medical Sciences, Department of Anaesthesiology, Sheikhpura, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
8986631508 |
| Fax |
|
| Email |
harshay029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Mumtaz Hussain |
| Designation |
Professor |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Ward Block 13, Near Neuro OT complex, Department of Anaesthesiology, Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna, Bihar, India
Indira Gandhi Institute Of Medical Sciences, Department of Anaesthesiology, Sheikhpura, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
9973152076 |
| Fax |
|
| Email |
drhussain72@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR HARSHA |
| Designation |
Junior Resident |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Ward Block 13, Near Neuro OT Complex, Department of Anaesthesiology, Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna
Indira Gandhi Institute Of Medical Sciences, Department of Anaesthesiology, Sheikhpura, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
8986631508 |
| Fax |
|
| Email |
harshay029@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF, Dr. Harsha, Junior Resident, Department of Anesthesiology, Ward Block 13, First Floor, Indira Gandhi Institute of Medical Sciences, Patna, Bihar India. Pin code 800014 |
|
|
Primary Sponsor
|
| Name |
DR HARSHA |
| Address |
Ward Block 13, first Floor, Near Neuro Ot Complex, Department of Anesthesiology, Indira Gandhi Institute Of Medical Sciences, Department of Anaesthesiology, Sheikhpura, Patna, Bihar, India Pin Code 800014 |
| Type of Sponsor |
Other [Self] |
|
|
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 Harsha |
Indira Gandhi Institute of Medical Sciences |
Ward Block 13, First Floor, Neuro OT (1-12) complex, Department of Anesthesiology,
Patna
BIHAR |
8986631508
harshay029@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, IGIMS |
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 |
| Comparator Agent |
Dexmedetomidine Group |
Dexmedetomidine at a dose of 0.5 mcg/kg of body weight via the subglottic port of the TuoRen Supra/subglottic Injectable endotracheal tube
Duration - 15 minutes Extubation Time |
| Intervention |
Lignocaine Group |
2% Lignocaine at a dose of 1.5mg/kg of body weight via the subglottic port of the TuoRen Supra/subglottic Injectable endotracheal tube
Duration - 15 minutes before Extubation Time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Consent for participation
2. Scheduled for elective surgery under genaral anaesthsia |
|
| ExclusionCriteria |
| Details |
Refusal of Patient.
2. With Known contraindication and sensitivity of study drugs
3. History of asthma or COPD
4. Who requires post op ventilation
5. Anticipated difficult airway
6. history of tracheal surgery |
|
|
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 the incidence and severity of coughing during emergence from general anesthesia |
Time POINT - JUST AFTER EXTUBATION, 1min post extubation, 2 min post extubation, 3 min post extubation, 4 min post extubation, 5 min post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Extubation Time
2. Hemodynamic Parameters
3. Surgeon satisfaction
4. Adverse Effects |
1. During Extubation
2. 1 min post extubation
3. 2 min post extubation
4. 3 min post extubation
5. 4 min post extubation
6. 5 min post extubation |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
01/09/2025 |
| 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 - NO
|
|
Brief Summary
|
So
far no study has detected the local
action of dexmedetomidine on tracheal mucosa in patients undergoing
endotracheal intubation. Therefore we hypothesize that direct instillation of
dexmedetomidine via supra/subglottic injectable endotracheal tube port could
suppress cough reflex following tracheal extubation.
This
prospective, randomized, double blinded trial will compare the safety and
efficacy of direct instillation of tracheal mucosa by dexmedetomidine and
lidocaine via a supra or subglottic injectable endotracheal port for smooth tracheal extubation in patients
undergoing general surgery. |