In short
Clinical trials are studying Sevoflurane in different patient groups, including children, older adults, intensive care patients, and people with stroke. These studies mainly look at safety, effectiveness, and patient outcomes such as memory, delirium, pain, breathing, kidney blood flow, and stroke-related brain injury.
Key points
- Clinical trials of Sevoflurane are studying many different patient groups, not just one disease. The largest studies look at older adults having major surgery, children having surgery, ICU patients at risk of ARDS, and adults with acute ischemic stroke. Most trials are Phase 3, which means they are larger studies that compare outcomes between treatment groups. The main outcomes include thinking skills, delirium, pain, oxygen levels, kidney blood flow, and brain injury after stroke. A smaller Phase 2 study also appears in pediatric surgery. Overall, the trial data focus on how Sevoflurane performs in real clinical settings and whether it improves important patient outcomes.
Trial overview
The trial data show that Sevoflurane is being studied in several different clinical settings, mostly around anesthesia and sedation. Most of the studies are Phase 3 trials, which are larger studies meant to compare outcomes across groups. One study is Phase 2, and one is listed as Low Intervention.
The studies include both completed and authorised trials. Enrollment ranges from 50 people to 1332 people, so the studies vary from small to very large.
Children and neurodevelopment
One important trial studies children under 2 years old who need surgery lasting at least 2 hours. The study compares low-dose Sevoflurane with dexmedetomidine and remifentanil against standard-dose Sevoflurane anesthesia. 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.
The main outcome is the full scale IQ score from the Wechsler Preschool and Primary School Intelligence Scale at 3 years of age. This tells researchers whether the anesthesia approach may affect later cognitive function, which is a broad term for thinking, learning, and problem-solving skills.
Another pediatric study looks at children after orthopedic trauma surgery and asks whether locoregional analgesia can help prevent persistent postoperative pain at 3 months. Sevoflurane is one of the anesthesia options used in this trial. 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.
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. Sevoflurane is part of the anesthesia regimen used in this study. The main endpoint is opioid consumption, measured as morphine oral equivalent, during the first 24 hours after surgery.
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. Sevoflurane is listed among the anesthesia drugs used in that study. 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.
Older adults and delirium
One large study looks at older patients having moderate- to high-risk major non-cardiac surgery. It compares desflurane, Sevoflurane, and propofol for maintenance of anesthesia. The main outcome is the incidence of postoperative delirium during the first five days after surgery.
Delirium is a sudden change in thinking and awareness, and it can be serious in older adults after surgery. This study is especially important because it asks whether the choice of anesthetic maintenance affects this complication.
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. The study is completed and includes 80 patients. The main outcome is the longitudinal change in the PaO2/FiO2 ratio, which is a measure of oxygen transfer in the lungs.
This trial is focused on whether inhaled Sevoflurane can improve breathing-related measures in critically ill patients who are at high risk for ARDS. The trial compares Sevoflurane with intravenous sedation options, so it is looking at a treatment strategy rather than only one drug alone.
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. The study compares propofol and Sevoflurane in children with postoperative acute kidney injury. The main outcome is the difference in renal blood flow measured by phase contrast imaging with mpMRI.
Another Phase 3 study, called the SAVE trial, is in adults with acute ischemic stroke who are having mechanical thrombectomy under general anesthesia. The trial compares Sevoflurane with propofol for anesthesia maintenance. 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.
Main study measures
The trials use different primary outcomes because they are studying different patient groups and different clinical questions. 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.
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.