Recovery of driving ability after propofol-only sedation

How long after propofol only sedation can endoscopy patients drive safely (less impaired than at 0.05 BAC)?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000634976

Enrollment

100

Registered

2011-06-22

Start date

2011-07-15

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Propofol is the trade name of the most commonly used intravenous general anaesthetic medication in Australia. This project will measure the level of impairment of driving skills after the administration of intravenous Propofol to a patient as part of an anaesthetic for gastrointestinal endoscopic procedures. Following informed consent, the patient’s ability to drive on a video-game style driving simulator will be measured immediately prior to their surgical procedure prior to any medications being administered. This will constitute the patient’s baseline driving skill level. The patient will then undergo their preplaned endoscopy procedure with propofol-only sedation. During the procedure, an extra cannula will be inserted in the opposite arm of the patient. After anaesthesia has been ceased, the patient's driving skill will be re-measured on the same simulator at regular intervals (30 minutes, 1 hour, 2 hours, 3 hours post cessation of anaesthesia). each simualtion will take approximately 10 minutes. Before each simulation, a blood sample will be taken from patients to determine the blood propofol concentration of the subjects.

Interventions

Propofol only anaesthesia - the dose of propofol will not be controlled and will be titrated to effect by the Anaesthetist using the intermittent bolus technique.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient undergoing elective endoscopy procedure

Exclusion criteria

Below 18 years Patient refusal Insufficient english to understand consent form Patient has illness impairing ability to drive a motor vehicle (may include absent limb or limbs, documented stroke, document intracranial tumour) Patient has multiple chronic illnesses Known allergy to propofol or any of its consituents e.g. egg, soy Patient taking medications known to interfere with metabolism or excretion of propofol Documented illness that may interfere with propofol metabolism or excretion e.g. liver failure No current driver's license Current driving license restrictions

Outcome results