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

Not Applicable

Withdrawn

• Conditions: Pain
• Interventions: Drug: Methoxyflurane

• Registration Number: NCT04292808
• Lead Sponsor: Verso Surgery Centre

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, 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Study Start: 2020-07
• Primary Completion: 2021-07
• Study Completion: 2021-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Conscious adult patients: ≥ 18 years of age
2. 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®).
3. Patient should understand the nature of the study and provide written informed consent
4. Patient is able to follow all study requirements and procedures and complete required questionnaires

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Exclusion Criteria

1. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
2. Clinically significant renal impairment
3. Women of child bearing potential who are pregnant or peri partum, including labour
4. A history of liver dysfunction after previous methoxyflurane use or other halogenated anesthetics
5. Hypersensitivity to methoxyflurane or other halogenated anesthetics, or to butylated hydroxytoluene
6. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
7. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
8. Clinically evident respiratory impairment as per the opinion of the investigator
9. Prior treatment with PENTHROX® within 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Penthrox	Methoxyflurane	Low Dose Methoxyflurane

Primary Outcome Measures

Name	Time	Method
Assessing patient satisfaction	through study completion, an average of 1 year	Global assessment of medication performance (gmp)

Trial Locations

Locations (1)

Verso Surgery Centre; 🇨🇦 Oakville, Ontario, Canada