METHOXYFLURANE 99.9% for Acute myocardial infarction

Inclusion criteria

• {"criterion_text":"- Patient age ≥ 18 years\n- Patient managed in pre-hospital setting for a ST elevation myocardial infarction (STEMI) : Douleur thoracique < 12 heures avec douleur modérée à sévère (EVA > 6/10).\n- Patient managed in pre-hospital setting for a ST elevation myocardial infarction (STEMI): STEMI on EKG according to 2018 ESC guidelines"}

Exclusion criteria

• {"criterion_text":"- Previous analgesic treatment for this episode of chest pain\n- - Clinical evidence of cardiovascular instability (PAS <90 mm Hg)\n- Altered level of consciousness due to any cause, including head trauma, drug or alcohol use.\n- Clinically significant renal impairment.\n- History of signs of liver damage after use of methoxyflurane or after anesthesia with a halogenated hydrocarbon.\n- Severe hepatocellular insufficiency (with encephalopathy),,\n- Acute head trauma and intracranial hypertension in the absence of controlled ventilation,\n- Uncontrolled epilepsy\n- Treatment with buprenorphine, nalbuphine and pentazocine, xyrem, naltrexone,\n- Breastfeeding, in case of initiation or continuation after birth of a long-term treatment.\n- Malignant hyperthermia: known malignant hyperthermia or genetic predisposition of the patient.\n- Contra-indication to morphine or methoxuflurane administration\n- History of serious adverse effects of the patient or his family after administration of inhaled anesthetics.\n- Incapacity to self-assess pain intensity\n- Incapacity to methoxyflurane self-administration\n- Pregnancy, minors or incapacity (tutelle, curatelle)\n- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants\n- Absence of a Social Security\n- Clinical evidence of respiratory depression.\n- Decompensated respiratory failure (in the absence of artificial ventilation),"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients achieving pain relief, i.e. pain intensity score on visual analogic scale (VAS) ≤ 3 at 30 minutes.","definition_or_measurement_approach":"Pain intensity measured using visual analog scale (VAS); outcome defined as VAS ≤ 3 at 30 minutes."}

Secondary endpoints

• {"endpoint_text":"- Pain relief: time before achieving pain relief, i.e. time between randomization and pain intensity score on VAS ≤ 3;","definition_or_measurement_approach":"Time (minutes) from randomization to VAS ≤ 3."}
• {"endpoint_text":"- Pain relief: time to reach initial pain divided by two (initial VAS / 2)","definition_or_measurement_approach":"Time (minutes) to reach a VAS equal to initial VAS/2."}
• {"endpoint_text":"- Impact of the treatments on cardiovascular system: heart rate, arterial blood pressure, pulse oximetry and ECG changes at hospital arrival","definition_or_measurement_approach":"Measurement of heart rate, arterial blood pressure, pulse oximetry (SpO2) and ECG changes recorded at hospital arrival."}
• {"endpoint_text":"- Tolerance of the treatments: respiratory depression: respiratory rate < 10 cycles per minutes","definition_or_measurement_approach":"Occurrence of respiratory depression defined as respiratory rate < 10 breaths per minute."}
• {"endpoint_text":"- Tolerance of the treatments: sedation: Richmond Agitation - Sedation Scale (RASS) ≥ 2 or ≤ -2","definition_or_measurement_approach":"Sedation assessed using RASS; event defined as RASS ≥ 2 or ≤ -2."}
• {"endpoint_text":"- Tolerance of the treatments: : dizziness, pruritus, nausea, vomiting, headache","definition_or_measurement_approach":"Occurrence of listed adverse symptoms (dizziness, pruritus, nausea, vomiting, headache) recorded as safety/tolerability outcomes."}

Methods

• Recruitment in the pre-hospital setting by emergency medical services (SAMU) in France targeting adult patients managed for ST-elevation myocardial infarction presenting within 12 hours with moderate to severe chest pain (VAS > 6/10).

France

Earliest CTIS Part Ii Submission Date

02-04-2025

Latest Decision Or Authorization Date

13-06-2025

Processing Time Days

72

Number Of Sites

10

Number Of Participants

700

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France