Table of Contents

• Trial overview
• Children and neurodevelopment
• Surgery and pain control
• Older adults and delirium
• ICU use and breathing outcomes
• Kidney and brain outcomes
• Main study measures

Trial overview

The trial data show that Sevoflurane is being studied in several different clinical settings, mostly around anesthesia and sedation.^[1][3][5] Most of the studies are Phase 3 trials, which are larger studies meant to compare outcomes across groups.^[1][3][5] One study is Phase 2, and one is listed as Low Intervention.^[2][4]

The studies include both completed and authorised trials.^{[1][2][3][4][5][6][7][8][9]} Enrollment ranges from 50 people to 1332 people, so the studies vary from small to very large.^{[1][2][3][4][5][6][7][8][9]}

Children and neurodevelopment

One important trial studies children under 2 years old who need surgery lasting at least 2 hours.^[1] The study compares low-dose Sevoflurane with dexmedetomidine and remifentanil against standard-dose Sevoflurane anesthesia.^[1] The main question is whether the lower-dose strategy is better for long-term neurocognitive development, which means how a child’s thinking and learning develop over time.^[1]

The main outcome is the full scale IQ score from the Wechsler Preschool and Primary School Intelligence Scale at 3 years of age.^[1] This tells researchers whether the anesthesia approach may affect later cognitive function, which is a broad term for thinking, learning, and problem-solving skills.^[1]

Another pediatric study looks at children after orthopedic trauma surgery and asks whether locoregional analgesia can help prevent persistent postoperative pain at 3 months.^[7] Sevoflurane is one of the anesthesia options used in this trial.^[7] The main outcome is pain measured by a Numerical Rating Scale, or NRS, which is a simple pain score given by the patient or caregiver report.^[7]

Surgery and pain control

In adults having lumbar arthrodesis, one Phase 3 study tests whether erector spinae plane block can reduce opioid use after surgery.^[3] Sevoflurane is part of the anesthesia regimen used in this study.^[3] The main endpoint is opioid consumption, measured as morphine oral equivalent, during the first 24 hours after surgery.^[3]

Another completed Phase 2 study in pediatric surgery compares two concentrations of chloroprocaine for peripheral nerve block in children having flat foot surgery or inguinal hernia repair.^[2] Sevoflurane is listed among the anesthesia drugs used in that study.^[2] The main goal is to see how many children do not need rescue anesthesia, which means extra anesthesia given if the first plan is not enough.^[2]

Older adults and delirium

One large study looks at older patients having moderate- to high-risk major non-cardiac surgery.^[5] It compares desflurane, Sevoflurane, and propofol for maintenance of anesthesia.^[5] The main outcome is the incidence of postoperative delirium during the first five days after surgery.^[5]

Delirium is a sudden change in thinking and awareness, and it can be serious in older adults after surgery.^[5] This study is especially important because it asks whether the choice of anesthetic maintenance affects this complication.^[5]

ICU use and breathing outcomes

A Phase 3 study in intensive care unit patients at risk of Acute Respiratory Distress Syndrome, or ARDS, compares inhaled Sevoflurane with current intravenous sedation practice.^[6] The study is completed and includes 80 patients.^[6] The main outcome is the longitudinal change in the PaO2/FiO2 ratio, which is a measure of oxygen transfer in the lungs.^[6]

This trial is focused on whether inhaled Sevoflurane can improve breathing-related measures in critically ill patients who are at high risk for ARDS.^[6] The trial compares Sevoflurane with intravenous sedation options, so it is looking at a treatment strategy rather than only one drug alone.^[6]

Kidney and brain outcomes

One pediatric Phase 3 study uses magnetic resonance imaging to assess how anesthesia affects renal perfusion, which means blood flow in the kidneys.^[8] The study compares propofol and Sevoflurane in children with postoperative acute kidney injury.^[8] The main outcome is the difference in renal blood flow measured by phase contrast imaging with mpMRI.^[8]

Another Phase 3 study, called the SAVE trial, is in adults with acute ischemic stroke who are having mechanical thrombectomy under general anesthesia.^[9] The trial compares Sevoflurane with propofol for anesthesia maintenance.^[9] The main outcome is final infarct volume on MRI at about 72 hours after treatment, which shows how much brain tissue was damaged by the stroke.^[9]

Main study measures

The trials use different primary outcomes because they are studying different patient groups and different clinical questions.^{[1][2][3][5][6][8][9]} These outcomes include IQ testing, no need for rescue anesthesia, opioid use after surgery, delirium rates, oxygenation, kidney blood flow, and final infarct volume after stroke.^{[1][2][3][5][6][8][9]}

Across the trial list, Sevoflurane is being studied in children, adults, older adults, and ICU patients, which shows that researchers are testing it in many real-world hospital settings.^{[1][3][5][6][7][8][9]}