Study to understand if numbing medicine given as fine spray through the mouth is effective in numbing the mouth and throat for facilitating insertion of breathing tube using a flexible cable with a camera at its end

Pilot study investigating the efficacy of lignocaine nebulisation through a mouthpiece for topical anesthesia of the upper airway for awake flexible bronchoscopy for adult patients undergoing elective surgeries requiring awake nasotracheal intubation for anticipated difficult intubation - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087454

Enrollment

Registered

2025-05-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Study arm: Nebulisation of 5 cc 4% lignocaine through mouth piece in patients planned for flexible bronchoscope guided awake nasotracheal intubation over around 15 minutes Control Inter

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged 18-80 years belonging to American Society of Anaesthesiologists physical status grade I and II posted for elective cancer surgery requiring awake flexible bronchoscopicnasotracheal intubation for an Anticipated difficult airway.

Exclusion criteria

Exclusion criteria: 1. Refusal of consent by patient. 2. Lignocaine allergy. 3. Patients with stridor. 4. Suspected difficult bronchoscopy e.g. Posterior pharyngeal wall tumors, proliferative base of tongue tumours. 5. Inability to apply mouthpiece to patients oral cavity e.g. restricted mouth opening, large intraoral tumours. 6. Patients who have undergone awake flexible bronchoscopy previously. 7. Baseline oxygen saturation of patients less than 95% on room air. 8. Reactive airway disease. 9. Refusal by the attending anesthetist.

Design outcomes

Primary

Measure	Time frame
Cough Score during passage of flexible bronchoscope (FB) into the tracheaTimepoint: On the day of intervention, at around 10-15 minutes after completion of intervention	—

Secondary

Measure	Time frame
1. Vocal cord movement during AFB. 2. Operator comfort score for FB. 3. Patient comfort scores will be subjectively assessed by asking for the patient s willingness to undergo an awake bronchoscopy again. 4. Cough Score during passage of endotracheal tube into the trachea 5. Total doses of lignocaine administered topically as spray as you go during bronchoscopy. 6. Any additional method of topicalisation e.g. transtracheal lignocaine injection due to poor operating conditions. 7. Additional sedative drugs used to improve patient comfort. Timepoint: all secondary outcomes except no 3 will be assessed on the day of intervention, at around 10-15 minutes after completion of intervention. Seconday outcome no 3 ( patient comfort score will be assessed on postoperative day 1 or 2	—

Measure

Time frame

1. Vocal cord movement during AFB. 2. Operator comfort score for FB. 3. Patient comfort scores will be subjectively assessed by asking for the patient s willingness to undergo an awake bronchoscopy again. 4. Cough Score during passage of endotracheal tube into the trachea 5. Total doses of lignocaine administered topically as spray as you go during bronchoscopy. 6. Any additional method of topicalisation e.g. transtracheal lignocaine injection due to poor operating conditions. 7. Additional sedative drugs used to improve patient comfort. Timepoint: all secondary outcomes except no 3 will be assessed on the day of intervention, at around 10-15 minutes after completion of intervention. Seconday outcome no 3 ( patient comfort score will be assessed on postoperative day 1 or 2

—

Countries

India

Contacts

Public ContactGaganeshwari Sawant

tata memorial centre, mumbai

gaganeshwari365@gmail.com9821514153

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026