5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

Last updated: January 13, 2021
Sponsor: All India Institute of Medical Sciences, New Delhi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bronchoscopy

Treatment

N/A

Clinical Study ID

NCT03869528
510 RCT
  • Ages > 18
  • All Genders

Study Summary

Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough.

Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All adults ≥ 18 yrs of age undergoing flexible bronchoscopy

Exclusion

Exclusion Criteria:

  • Uncontrolled hypertension Systolic Blood Pressure >180 mm Hg
  • Symptomatic coronary artery disease
  • Pregnancy
  • Not giving informed consent for the procedure
  • Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
  • Bronchoscopy performed through an artificial airway

Study Design

Total Participants: 300
Study Start date:
April 01, 2019
Estimated Completion Date:
December 01, 2021

Study Description

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. Enrolled patients will be randomized to receive either 5 or 10 sprays of 10% lignocaine to the pharynx. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine administered as "spray as you go" method. This will be given as 2 ml aliquots- with similar volume in both groups as baseline. Procedure shall be performed with administration of sedation using Midazolam and Fentanyl if required. Primary outcome will be assessed by noting the operator rated overall procedure satisfaction as a VAS scale score.

Connect with a study center

  • AIIMS

    New Delhi, 110029
    India

    Active - Recruiting

  • AIIMS Rishikesh

    Rishīkesh,
    India

    Active - Recruiting

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