WithdrawnNot Applicable

Low Dose Methoxyflurane and Out-Patient Aesthetic Surgery and Facial Filler

Stopped: Covid caused too many delays

Canada0Started 2020-07

Plain-language summary

The aim of the study is to generate real-world evidence on the effectiveness, safety and additional parameters of low dose methoxyflurane (PENTHROX®) in: aesthetic surgeries (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) and facial filler injections \[eg. hyaluronic acid (HA) and Sculptra®\] in an outpatient aesthetic practice. This will be an open-label study, with a total of 60 patients undergoing a planned outpatient aesthetic surgery or filler injection (30 patients in each group).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Conscious adult patients: ≥ 18 years of age
✓. Patient is scheduled for an outpatient anesthetic surgery (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) or a facial filler injection (eg. HA, and Sculptra®).
✓. Patient should understand the nature of the study and provide written informed consent
✓. Patient is able to follow all study requirements and procedures and complete required questionnaires

Exclusion criteria

✕. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
✕. Clinically significant renal impairment
✕. Women of child bearing potential who are pregnant or peri partum, including labour
✕. A history of liver dysfunction after previous methoxyflurane use or other halogenated anesthetics
✕. Hypersensitivity to methoxyflurane or other halogenated anesthetics, or to butylated hydroxytoluene
✕. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
✕. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
✕. Clinically evident respiratory impairment as per the opinion of the investigator

What they're measuring

Assessing patient satisfaction

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT04292808

SponsorVerso Surgery Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07

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