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

Verso Surgery Centre

Status: Withdrawn

Conditions: Pain

Treatments: Drug: Methoxyflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT04292808

PRO00040577

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Penthrox

Other group

Description:

Low Dose Methoxyflurane

Treatment:

Drug: Methoxyflurane