None listed
Conditions
Brief summary
This double-blinded, randomised controlled clinical trial of healthy physician volunteers is designed to determine if a difference exists in the median and range of plasma lignocaine concentrations (mcg/ml) in healthy volunteers for two preparations of lignocaine [topical 4% lignocaine diluted to 2% (as currently used by the Gosford awake fibreoptic intubation course) and alkalinised 2% intravenous lignocaine (1ml 8.4% sodium bicarbonate per 10ml 2% IV lignocaine)] when used for topicalisation of the airway for endoscopy. We will also look at comfort scores of participants.
Interventions
Airway topicalisation with 2% lignocaine for injection, alkalinised with bicarbonate, given by nebuliser and topical spray to nose and mouth, by course participant (anaesthesia or emergency physician) in divided doses according to our protocol up to that needed to achieve successful endoscopy, to a maximum dose of 9mg/kg over 30 minutes (maximum lignocaine dose given pre-calculated for person who is being topicalised taking into account all doses of lignocaine applied the expected period of top
Airway topicalisation with 2% lignocaine for injection, alkalinised with bicarbonate, given by nebuliser and topical spray to nose and mouth, by course participant (anaesthesia or emergency physician) in divided doses according to our protocol up to that needed to achieve successful endoscopy, to a maximum dose of 9mg/kg over 30 minutes (maximum lignocaine dose given pre-calculated for person who is being topicalised taking into account all doses of lignocaine applied the expected period of topicalisation (30 minutes))
Sponsors
Department of Anaesthesia, Gosford Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Outcome results
None listed