Not Yet RecruitingPhase 4ACTRN12611000634976

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)?


Sponsor

Department of Anaesthesia - Monash Medical Centre

Enrollment

100 participants

Start Date

Jul 15, 2011

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Patient undergoing elective endoscopy procedure

Exclusion Criteria10

  • 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

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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.

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.


Locations(1)

Australia

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ACTRN12611000634976