Comparing blood levels of two preparations of 2% lignocaine for airway anaesthesia.

Phase 3

Completed

• Conditions: Airway topicalisation; plasma lignocaine levels; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12620000730909
• Lead Sponsor: Department of Anaesthesia, Gosford Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-13
• Study Completion: 2024-05-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The study population will be healthy physician volunteers who are prepared to attend the awake fibreoptic intubation course.
Physicians must be on a critical care training programme or have completed such a programme – i.e. likely to be conducting topicalisation and AFOI on patients in the future in order to ensure a baseline of understanding of the procedure and its risks and benefits.
Physicians must be complete or relative novices at topicalisation and AFOI – i.e. completed less than 5 AFOI previously.
Physicians must be healthy - as determined by Gosford Awake Fibreoptic Course medical screening questionnaire.
Physicians must have read and understood the participant information & consent forms and be willing to give written informed consent and
Physicians must be willing to participate to and comply with the study.
Physicians must agree to safety precautions.

Exclusion Criteria

Non-physician or non-critical care training/ed.
Unhealthy as determined by Gosford Awake Fibreoptic Course medical screening questionnaire.
Contraindications to endoscopy including epistaxis (nosebleeds), history of significant ear,nose,throat diseases (ENT pathology including laryngospasm), current upper respiratory tract infection (cold), blocked nose for any reason, current respiratory problems (breathing difficulties), previous CVA (stroke).
Affecting lignocaine levels - Cardiac or liver failure (lignocaine metabolism changes), Pregnant or lactating, Obesity (BMI >35), having received lignocaine by any route in prior 24hrs.
Allergy to local anaesthetics (lignocaine)
Failure to obtain intravenous (IV) access
Anaemia or anticoagulated (blood samples).
Medications that could affect lignocaine metabolism (liver affects).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the plasma lignocaine level attained by the two preparations (Diluted 2% Topical lignocaine versus Alkalinised 2% intravenous lignocaine) in healthy volunteers, with a standardised method of upper airway topicalisation for endoscopy.[ at 15, 30, 45 60, 75 and 90 minutes from the end of nebulization]

Secondary Outcome Measures

Name	Time	Method
To compare the difference in mean total dose of lignocaine required by the two preparations in ml and mg (Diluted 2% Topical lignocaine versus Alkalinised 2% intravenous lignocaine) to achieve upper airway endoscopy in healthy volunteers, with a standardised method of upper airway topicalisation. This will be measured by dose required for successful endoscopy to the carina[ end of topicalisation];To compare the difference in patient experience (visual analogue scales (VAS) of discomfort) between the two preparations (Diluted 2% Topical lignocaine versus Alkalinised 2% intravenous lignocaine) in healthy volunteers, with a standardised method of upper airway topicalisation for endoscopy.[ at end of topicalisation]