| CTRI Number |
CTRI/2024/06/068262 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This is a study to Compare how well nebulization with lignocaine alone and lignocaine with dexmedetomidine works for patients going for awake nasal intubation using a fiber optic scope. |
|
Scientific Title of Study
|
Comparison of effectiveness of
nebulization with lignocaine alone or with dexmedetomidine in patients undergoing awake nasotracheal intubation under fiber optic guidance. |
| 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 Renu Bala |
| Designation |
Professor |
| Affiliation |
Pt. B D Sharma, PGIMS, Rohtak |
| Address |
Department of Anaesthesiology &
Critical Care, 2nd floor Modular OT complex Pt. B D Sharma, PGIMS,
Rohtak
Rohtak HARYANA 124001 India |
| Phone |
8901322251 |
| Fax |
|
| Email |
neurodmrenu@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jitendra Kumar |
| Designation |
Junior resident |
| Affiliation |
Pt. B D Sharma, PGIMS, Rohtak |
| Address |
Department of Anaesthesiology &
Critical Care, 2nd floor Modular OT complex Pt. B D Sharma, PGIMS,
Rohtak
Rohtak HARYANA 124001 India |
| Phone |
7210373666 |
| Fax |
|
| Email |
jitendrakr99@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jitendra Kumar |
| Designation |
Junior resident |
| Affiliation |
Pt. B D Sharma, PGIMS, Rohtak |
| Address |
Department of Anaesthesiology &
Critical Care, 2nd floor Modular OT complex Pt. B D Sharma, PGIMS,
Rohtak
Rohtak HARYANA 124001 India |
| Phone |
7210373666 |
| Fax |
|
| Email |
jitendrakr99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak, 124001 Haryana India |
|
|
Primary Sponsor
|
| Name |
Institute Department of Anaesthesiology and Critical care PGIMS ROHTAK |
| Address |
Department of Anaesthesiology And Critical Care
2nd floor Modular OT complex
Pt B D Sharma PGIMS
Rohtak
Haryana
124001
India
|
| 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 Jitendra Kumar |
Pt. B D Sharma, PGIMS, Rohtak |
Department of Anaesthesiology &
Critical Care, 2nd floor Modular OT complex Pt. B D Sharma, PGIMS,
Rohtak Rohtak HARYANA |
7210373666
jitendrakr99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committiee pt. B. D. Sharma PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1 Lignocaine
2 Dexmedetomidine |
Group with Lignocaine nebulization alone, drug will be prepare with 5ml of 4% Lignocaine to which 1ml Normal saline will be added. Total drug volume will be 6 ml.
In another drug group dexmedetomidine 100mcg/ml will be taken in insulin syringe and 1mcg/kg will be added to 5ml of 4% Lignocaine and further diluted with normal saline to make total drug volume of 6 ml. After 20mins of nebulization effect of local anaesthetics will be confirmed by heaviness of tongue and hoarseness of voice |
| Intervention |
Comparison of effectiveness of drugs for nasotracheal intubation under fiber optic guidance |
Comparison of effectiveness of nebulization with lignocaine alone or with dexmedetomidine in patients undergoing awake nasotracheal intubation under fiber optic guidance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A total of 50 patients, age group 18-60 years, either gender, belonging to ASA physical status I, II having anticipated difficult airways schedule to undergo elective surgery under general anaesthesia and requiring endotracheal intubation will be enrolled. |
|
| ExclusionCriteria |
| Details |
Refusal to participation, non-cooperative patient, Psychiatric conditions, Allergic to study drugs, Bradycardia and hypotension, Nasal pathology, Coagulation abnormalities, Intracranial hypertension & glaucoma, Pregnancy and lactation.
|
|
|
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 |
| Time required for intubation |
At the baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success rate,
Number of attempts taken,
Ease of intubation as per intubation difficulty score (IDS)
|
At the baseline. |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="1" Months="0" 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
|
Airway management has significantly improved, but difficult airways remain a major challenge for anesthetists, causing 25% of anesthesia-related deaths. When a difficult airway is expected, securing the airway while the patient is awake is the safest approach. Fiberoptic bronchoscopy, introduced in 1967, is the gold standard for managing difficult airways, with a success rate of 88%-100%. It allows direct guidance and can be performed while the patient is awake, maintaining oxygenation. Effective airway anesthesia is essential and can be achieved using local anesthetics through various techniques, such as sprays, gargles, and nebulization, or by blocking specific nerves. Nebulization is simple, non-invasive, and effective for awake fiberoptic intubations, though it might need supplementation with nerve blocks or the spray-as-you-go (SAYGO) technique. Dexmedetomidine, an α2 adrenoreceptor agonist, provides sedation without significant respiratory depression and reduces salivary secretions, making it suitable for awake fiberoptic intubation. It has anxiolytic, hypnotic, analgesic, amnesic, and antisialogogue properties. Nebulized dexmedetomidine, combined with lidocaine, has been effective for awake videoendoscopic intubations, reducing coughing and recovery time. This study aims to evaluate the effectiveness of adding dexmedetomidine to lignocaine nebulization for awake fiberoptic nasotracheal intubation in patients with predicted difficult airways, as current literature lacks sufficient evidence-based recommendations. |