To Compare two techniques of local anaesthesia to airway by using either ultrasound assisted local anesthesia drug injection or nebulisation with local anesthesia drug, for inserting tracheal tube into airway in conscious patient

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2019/08/020676
• Lead Sponsor: Department of anesthesiology

Brief Summary

To compareefficacy between  nebulized lignocaine and ultrasoundguided airway  nerve blocks for awake  fiberoptic intubation.

To assess cough reflex and gag reflexduring awake fiberopticintubation

A prospective, randomized, observerblinded study. Sample size - with confidence interval 95%, α is0.05 , powerof 80%, β is 0.2,60 patients are needed.

A written informed consent.

Randomly assigned into 2 groups by usingsealed envelope technique.

Standard fastingprotocol and anti-aspiration prophylaxis.

GROUP 1 (LA) – NEBULISATION WITH 4ML OFLIGNOCAINE 4%

GROUP 2 (UAB) – USG GUIDED  AIRWAY NERVE BLOCK– 2mlof 2% lignocaine - B/L superior laryngeal nerve andrecurrent laryngeal nerve.

Confirmation ofthe tube in the trachea by end-tidal capnography.

•Hemodynamic parameters,such as systolic blood pressure (SBP), diastolic blood pressure (DBP), HR, SpO2 , ECG will be recorded as base linein preoperative room. Then vitals will be recorded  during FOB intubation, immediately afterintubation, 5 min, 15 min of intubation inside OT.

•Gag reflex, cough reflex, vocal cordposition will be noted during intubation

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-09
• Last Update Posted: 2019-09-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Mallampati grade 3 & 4 or inter-incisor distance <2.5 cm ASA grade 1,2,3 Patients having mouth opening < 3 fingers, patients with a short neck and long teeth, micrognathia, obesity and cellulitis of the tongue.
• Large oropharyngeal tumors, obstructing laryngeal tumors, congenital and acquired maxillofacial deformities, ankylosis of the temporomandibular joints, fractures or ankylosing spondylitis of the cervical spine, and all patients with a history of previous intubation problems.
• Trauma – facial lacerations/ fractures, cervical spine instability, upper airway lacerations etc.

Exclusion Criteria

Significant glottis and subglottic obstructions Blood and secretions in oral cavity Allergy to local anesthetics / ultrasound gel Hemodynamic instability Infection at local site Previous neck surgery Epileptics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cough reflex	1. Cough reflex at a time point when fibreoptic bronchoscope is passing through pharynx, during awake intubation | 2. Gag reflex at a time point when fibreoptic bronchoscope is passing through larynx, during awake intubation
2. Gag reflex	1. Cough reflex at a time point when fibreoptic bronchoscope is passing through pharynx, during awake intubation | 2. Gag reflex at a time point when fibreoptic bronchoscope is passing through larynx, during awake intubation

Secondary Outcome Measures

Name	Time	Method
Heart rate, blood pressure, partial pressure of oxygen saturation	1. Pre-operatively at a time point 10 minutes before shifting to operation theatre
Duration of intubation	Time point from entry of fibreoptic bronchoscope through nose to the endotracheal tube placement, during awake intubation
Facial grimace
Vocal cord visibility	At a time point when fiberoptic bronchoscope is passing through vocal cord

Trial Locations

Locations (1)

AIIMS Rishikesh; 🇮🇳 Dehradun, UTTARANCHAL, India

AIIMS Rishikesh

🇮🇳Dehradun, UTTARANCHAL, India

Dr Jharana Mohanta

Principal investigator

9650524150

cooljharana@gmail.com