| CTRI Number |
CTRI/2024/06/068473 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare airway blocks, local anaesthetic
nebulization and Spray as you go technique for awake flexible bronchoscope
assisted nasotracheal intubation
|
|
Scientific Title of Study
|
Comparative effect of airway blocks, local anaesthetic
nebulization and Spray as you go technique for awake flexible bronchoscope
assisted nasotracheal intubation: A Randomized Interventional Study at SMS Medical College, Jaipur |
| 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 Sushil Bhati |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology,
Second floor, Dhanwantari OPD Block, SMS Medical College,
jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414779786 |
| Fax |
|
| Email |
Drsushilbhati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Bhati |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology,
Second floor, Dhanwantari OPD Block, SMS Medical College,
jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414779786 |
| Fax |
|
| Email |
Drsushilbhati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
URVIKA SHARMA |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Anaesthesiology,
Second floor, Dhanwantri OPD Block, SMS Medical College,
jaipur, Rajasthan
Jaipur
RAJASTHAN
302019
India |
| Phone |
9680225521 |
| Fax |
|
| Email |
04urvikasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical College And Attached Hospitals, Jaipur, Rajasthan, India-302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College And Attached Hospitals |
| Address |
JLN Marg, Adarsh Nagar, Jaipur, Rajasthan, India - 302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Sushil Bhati |
SMS Medical College And Attached Hospitals |
Department of Anaesthesiology,
Second floor, Dhanwantari OPD Block, SMS Medical College And Attached Hospitals, JLN Marg, Adarsh Nagar, jaipur, Rajasthan
Jaipur
RAJASTHAN |
9414779786
Drsushilbhati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical CollegeAnd Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Airway Block |
Transtracheal block using 4ml of 4% lignocaine and bilateral superior laryngeal nerve block using 2ml of 2% lignocaine on each side in patients (5-8 min) undergoing awake flexible bronchoscope assisted nasotracheal intubation for head and cancer surgery to check the efficacy of airway anaesthesia |
| Intervention |
Local anaesthetic nebulization |
Nebulization using 4ml of 2% lignocaine for 10 min in patients undergoing awake flexible bronchoscope assisted nasotracheal intubation for head and cancer surgery to check the efficacy of airway anaesthesia |
| Comparator Agent |
Spray as you go |
Say go technique using 2% lignocaine (wait for 5-8 min) in patients undergoing awake flexible bronchoscope assisted nasotracheal intubation for head and cancer surgery to check the efficacy of airway anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing Head and Neck Cancer surgeries requiring awake nasotracheal intubation with flexible bronchoscope.
2. Patients willing to participate in the study
3. Adult patients aged between 30-80 Years of either gender
4. Patients belonging to American Society of Anesthesiologists (ASA) grade
I, II and III |
|
| ExclusionCriteria |
| Details |
1.Patient should not be a part of other study
2.Patients with the history of obstructive sleep apnea, nasal trauma, nasal surgery and bleeding diathesis
3.Patients with history of allergy to the study drugs.
4.Non cooperative patients.
5.Coagulopathies, any neuropathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean time taken for intubation ( in seconds) from introduction of tip of flexible
bronchoscope in the nostril till the cuff of endotracheal tube crosses vocal cords
2. Percentage of Intubation score
3. Percentage of Five point Patient comfort score
|
During time of fibroscopy and intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean of hemodynamic variables ( SBP, DBP, MAP, HR, SpO2)
2. Percentage of complications ( Bradycardia, Tachycardia, Hypertension, laryngospasm,
trauma |
Baseline
At the time of induction
Before fibrescopy
1 min after intubation
3 min after intubation
5 min
10 min
20 min
30 min
60 min
90 min |
|
|
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 4 |
|
Date of First Enrollment (India)
|
14/06/2024 |
| 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
|
Flexible bronchoscopy assisted nasotracheal intubation is the standard technique in patients undergoing head and neck cancer surgeries. Awake flexible bronchoscopy is usually recommended in difficult airway situations
because an awake patient can sustain ventilation and oxygenation without assistance,
pharyngeal muscle tone and phonation are preserved, can swallow its secretions thus
keeping the pharynx clear and other alternatives to deal with the difficult airway can still
be used. Thus it is essential to anesthetize the upper airway adequately and suppress the gag,
swallow, and cough reflexes prior to awake flexible bronchoscope (FOB) guided
intubation to ensure patient comfort. The various techniques for local anaesthesia of the airway include nebulisation using a
nebuliser, spraying local anaesthetic directly over the mucosa through the working
channel of the flexible bronchoscope which is also called ‘spray as you go’ technique
or by giving nerve blocks. |