CTRI Number |
CTRI/2023/01/049238 [Registered on: 25/01/2023] Trial Registered Prospectively |
Last Modified On: |
22/11/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
A clinical trial to study the effect of 3 drugs, dexmedetomidine, fentanyl, ketamine in addition to lignocaine nebulization for anesthetizing airway in patients undergoing awake fibreoptic intubation. |
Scientific Title of Study
|
Comparison of dexmedetomidine, fentanyl, ketamine nebulization as an adjuvant to lignocaine for awake fibreoptic intubation. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Arya s jith |
Designation |
Post graduate student |
Affiliation |
YENEPOYA UNIVERSITY |
Address |
ARYA.S.JITH,M.Sc.Anaesthesia and operation theatre technology student, Yenepoya school of allied health science, yenepoya [Deemed to be university],Mudipu, Mangalore
Dakshina Kannada KARNATAKA 574153 India |
Phone |
8129164668 |
Fax |
|
Email |
aryasuja786@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrSmita Musti |
Designation |
Associate Professor |
Affiliation |
Yenepoya Medical College, Mangalore |
Address |
Smita Musti
Associate Professor
Department of Anaesthesia
Yenepoya Medical College, Yenepoya (Deemed to be University) Deralakatte
Mangalore S S Musti
#2399, Yalakki Oni
Haveri 581110 Haveri KARNATAKA 575018 India |
Phone |
9886125842 |
Fax |
|
Email |
smitamusti@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrSmita Musti |
Designation |
Associate Professor |
Affiliation |
Yenepoya Medical College, Mangalore |
Address |
Smita Musti
Associate Professor
Department of Anaesthesia
Yenepoya Medical College, Yenepoya (Deemed to be University) Deralakatte
Mangalore S S Musti
#2399, Yalakki Oni
Haveri 581110 Haveri KARNATAKA 575018 India |
Phone |
9886125842 |
Fax |
|
Email |
smitamusti@gmail.com |
|
Source of Monetary or Material Support
|
yenepoya medical college hospital |
|
Primary Sponsor
|
Name |
Yenepoya medical college hospital |
Address |
yenepoya medical college hospital, yenepoya(deemed to be university),Deralakatte,Manglore-575018 |
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 Smita Musti |
Yenepoya Medical College Hospital |
Room no:6,1
Operation theatre complex,
6th floor and 3rd floor,
Department of Anaesthesiology, Deralakatte, Dakshina kannada, Mangalore-575018 Dakshina Kannada KARNATAKA |
9886125842
smitamusti@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Yenepoya Ethics Committee 2 |
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 |
4% Lignocaine |
lignocaine dose-160 mg, Route -inhalational, frequency -single dose, duration -20min. |
Intervention |
4% lignocaine with
Dexmedetomidine
|
4% Lignocaine-Dose-160mg, Route-Inhalational route,Duration-20min, Frequency-Single dose.
Dexmedetomidine- Dose-1 mcg/kg, Route-Inhalational route, Duration-20 min, Frequency-Single dose.
|
Intervention |
4% Lignocaine with Fentanyl |
4% Lignocaine-160mg
Fentanyl-2mcg/kg Fentany-Dose-2mcg/kg, Route-Inhalational route,Duration-20 min, Frequency-Single dose.
Ketamine- Dose-2mg/kg, Route-Inhalational route,Duration-20 min, Frequency-Single dose. |
Intervention |
4% Lignocaine with Ketamine |
4% Lignocaine 160mg+Ketamine- Dose-2mg/kg, Route-Inhalational route,Duration-20 min, Frequency-Single dose |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients under the category of ASA I/II(American Society of Anaesthesiologist). |
|
ExclusionCriteria |
Details |
1.Previous Airway surgery
2.Anticipated difficult airway
3.Nasal Trauma
4.Allergy to Local Anesthetics |
|
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 |
1.To determine the cough score.
2.To determine the rate of glottic closure during bronchoscopy and intubation. |
the time from the starting of intubation till the tube reaches the trachea (about 30sec) |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To evaluate sedation score.
2.To observe for any other adverse effects. |
the time from the intubation till securing the airway(about 60 sec) |
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/02/2023 |
Date of Study Completion (India) |
31/08/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, parallel group, single centre trial comparing the effect of dexmedetomidine(1 mcg/kg), fentanyl( 2 mcg/kg), ketamine( 2mg/kg) in addition to 4 % lignocaine (160mg) nebulization during awake fibreoptic intubation. The primary outcome measures will be the cough score and rate of glottic closure at the time from the starting of intubation till the tube reaches the trachea. The secondary outcomes will be sedation score and to observe for other adverse effects. |