| CTRI Number |
CTRI/2024/09/073165 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [nerve block and nebulization] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of jet nebulization of lignocaine and airway nerve block for achieving airway anesthesia before awake fiberoptic bronchoscopy- guided. |
|
Scientific Title of Study
|
Comparison between lignocaine nebulization and airway nerve block for awake fiberoptic bronchoscopy-guided nasotracheal intubation: a single-blind randomized prospective 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 |
Aryan Chahal |
| Designation |
Anaesthesia Resident |
| Affiliation |
MM Institute of Medical Sciences and Research Centre, Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8570888224 |
| Fax |
|
| Email |
chahalaryan5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Nandan Prasad |
| Designation |
Professor |
| Affiliation |
MM Institute of Medical Sciences and Research Centre, Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
6283155919 |
| Fax |
|
| Email |
hersimran89mbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram Nandan Prasad |
| Designation |
Professor |
| Affiliation |
MM Institute of Medical Sciences and Research Centre, Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
6283155919 |
| Fax |
|
| Email |
hersimran89mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
MM Institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana 133207, India |
|
|
Primary Sponsor
|
| Name |
Dr Ram Nandan Prasad Professor Department of Anaesthesia |
| Address |
MM Institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana 133207, India |
| Type of Sponsor |
Private 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 Aryan Chahal |
MM Institute of Medical Sciences and Research Centre, Ambala |
Department of Anaesthesiology, MM Institute of Medical Sciences and Research Centre, Ambala
Ambala
HARYANA |
8570888224
chahalaryan5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, MMIMSR, Mullana Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Posted for elective surgery
and Patient having facial fractures, cervical spine instability, craniofacial abnormalities and some partial obstructive laryngeal lesions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
airway nerve block |
Group B will receive 1 ml of 2% lidocaine gel will be first instilled into the
nasal mucosa then, followed by bilateral superior laryngeal nerve block and transtracheal
instillation of 2 ml of 2% lidocaine. |
| Comparator Agent |
lidocaine nebulization |
Group N will be given 10 ml of 4% lidocaine via a pneumatic (jet)
nebulizer for 15 min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ASA II and BMI between 20-35 |
|
| ExclusionCriteria |
| Details |
1. Patients who will not provide consent.
2. Contradictions or allergy to any study drug.
3. Patient having asthma, epilepsy, hemodynamically instability, or a deranged coagulation
profile.
4. Pregnant and Breast- feeding women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intubation time of the two techniques |
Intaoperative period of the two techniques |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the quality of airway anesthesia, the degree of patient comfort, and post-operative
patient satisfaction. |
Intraoperative and post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/09/2024 |
| 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 is an important part of anesthesia, providing ventilation, oxygenation, preventing aspiration, and working as a mode of distribution anesthetic gasses. This is an important skill and area of focus for the anesthetist because sometimes it is very difficult to maintain or manage the airway and this can be life-threatening. The awake fiberoptic endoscope intubation (AFOI) technique is the gold standard in the treatment of patients with suspected airway difficulty, especially before induction of anesthesia.1 It is important to prepare patients before AFOI. The thought of being awake and having a nasotracheal procedure can be very stressful for a patient who is not mentally prepared, so adequate time and effort should be spent preparing patients and by using different pharmacological modalities. The anesthesiologist should guide and prepare the patients by explaining procedure in details in their mother tongue. 2 Preparation also includes blocking airway reflexes, providing adequate sedation, preventing anxiety and maintaining airway patency and adequate ventilation. Awake fiberoptic intubation includes facial fractures, cervical spine instability,some partial obstructive laryngeal lesions (e.g., papilloma), craniofacial abnormalities, and temporomandibular joint ankylosis. 3,4 It can also be used to maintain the patency of airway in several conditions like in cervical spine unstability where manipulation of patient’s neck is likely to be difficult. In cases where cervical spine immobile or instable, applying of rigid cervical collar can reduce cervical spine movements and it hampers tracheal intubation by using standard laryngoscope.5 This procedure reduces the risk of nerve damage before the onset of surgical procedure. Before intubation under awake FOB guidance, it is essential to sufficiently anesthetize upper airway and suppress the swallow, gag and coughing reflexes prior to guided intubation and thus ensure patient comfort.6 This can be attained by different ways, which can be divided into two groups: (a) Local application of local anesthetic agent, or (b) blockade of neural supply to oropharynx and larynx.Local applications of LA in sprays, mouthwashes, lozenges, or nebulized forms cause less damage to the airway compared to nerve blocks. Also, the risk of inadvertent injection into blood vessels is avoided. In contrast, nerve block techniques usually require a small amount of local anaesthetic, which may reduce risk of systemic toxicity. 7Airway nerve blocks are in the form of glossopharyngeal, superior laryngeal (SLN) and trans tracheal block to abolish gag reflex, closure of the glottis and reflex coughing. 8 To complete anesthesia, it is recommended to block the glossopharyngeal nerve (GPN) and superior laryngeal nerve (SLN) both sides and transtracheal injection for recurrent laryngeal nerve. Glossopharyngeal nerve can be blocked intraorally and extraorally but it is associated with complications and it is recommended not to use the later approach due to close proximity of the vagus nerve. 9 Airway nerve blocks are mostly used for awake fiberoptic intubation because they provide rapid and deep anesthesia. Nebulization of local anesthetics is also effective technique, which provide complete anaesthesia without the need for multiple painful injections. Therefore, we will compare nerve block, which is considered the standard procedure for achieving rapid and effective airway anesthesia, with lignocaine nebulization, which constitutes a simple, painless, and comfortable alternative method for anesthetizing the airway. When carried out under minimal sedation these techniques help to allay anxiety so the patient is more cooperative during the procedure. In our study, before awake fiberoptic bronchoscopy-guided intubation, we used dexmedetomidine infusion for procedural sedation, which results in a stable hemodynamic profile and prevents desaturation by preserving the respiratory function of the patient. This randomized study will be conducted to compare the efficacy of jet nebulization of lignocaine and airway nerve block for providing airway anesthesia before awake fiberoptic bronchoscopyguided intubation. |