Status:
WITHDRAWN
Low Dose Methoxyflurane and Out-Patient Aesthetic Surgery and Facial Filler
Lead Sponsor:
Verso Surgery Centre
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, uppe...
Eligibility Criteria
Inclusion
- 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
- 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
- Prior treatment with PENTHROX® within 3 months
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04292808
Start Date
July 1 2020
End Date
July 1 2021
Last Update
May 6 2023
Active Locations (1)
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1
Verso Surgery Centre
Oakville, Ontario, Canada, L6J 0A3