In short
Clinical trials are investigating Rocuronium Bromide in children, adults, and healthy volunteers. These studies look at how it is used during anesthesia and intubation, and they measure safety, effectiveness, reversal of muscle block, and airway outcomes. The target groups include infants, children under 2 years, adults with obesity, adults with respiratory distress, stroke patients, and surgical patients.
Key points
- Clinical trials of Rocuronium Bromide are being done in infants, children, adults, and healthy volunteers. The studies mostly focus on anesthesia, intubation, and how muscle block is monitored or reversed. Some trials look at dose finding in young children, while others compare intubation conditions, airway changes, or recovery time after anesthesia. The trial phases are mainly Phase 2 and Phase 3, with some low-intervention studies. The main outcomes include safety events, successful intubation, reversal of muscle block, airway measurements, and time to return of breathing.
Trial overview
These clinical trials study Rocuronium Bromide in real patient care settings, mainly during anesthesia, intubation, and surgery.
The studies are looking at how well it works in different groups, how quickly muscle function returns, and whether certain methods improve safety or airway conditions.
Who is being studied
The target populations are very different across the trials.
- Infants having surgery for craniosynostosis, which is an early fusion of skull bones.
- Children under 2 years old who need rocuronium and then reversal with sugammadex.
- Adults having tracheal intubation with video laryngoscopy, which uses a camera to help place a breathing tube.
- Patients with residual neuromuscular blockade after extubation, meaning some muscle weakness remains after the breathing tube is removed.
- Morbidly obese patients, defined in the trial as BMI at least 40 kg/m².
- Adults needing emergency tracheal intubation because of respiratory distress.
- People with acute ischemic stroke undergoing mechanical thrombectomy, a procedure to remove a clot and restore blood flow.
- Patients having lumbar arthrodesis, which is surgery to fuse bones in the lower spine.
- Pediatric patients scheduled for elective surgery under general anesthesia.
- Healthy volunteers in a study of recovery from general anesthesia.
Trial phases and study types
Most of the trials are Phase 3 studies, which usually means they are testing outcomes in larger groups and comparing different clinical strategies.
One study is Phase 2 and focuses on dose determination in children under 2 years of age.
Two studies are described as Low Intervention, meaning the research is focused on care strategies rather than testing a new drug plan alone.
Main endpoints being measured
The trials measure different endpoints, which are the main results the researchers want to learn from the study.
- How much sevoflurane or propofol changes the properties of rocuronium at different doses in infants.
- The total dose of sugammadex needed to achieve complete decurarisation, meaning full reversal of muscle block, in children under 2 years.
- Failed first-pass intubation, meaning the breathing tube is not placed successfully on the first try.
- Airway cross-sectional area during residual neuromuscular blockade and after reversal.
- Excellent intubation conditions in morbidly obese patients when Rocuronium Bromide is dosed by ideal body weight or real body weight.
- Severe intubation-related complications in the first hour after emergency intubation.
- Time from hospital arrival to arterial recanalization, which means reopening the blocked artery in stroke treatment.
- Postoperative opioid use after lumbar arthrodesis with and without erector spinae plane block.
- How often sugammadex is used at the end of anesthesia in pediatric surgery.
- Time to the return of spontaneous breathing after general anesthesia in healthy volunteers.
Main study focuses
Several trials focus on how Rocuronium Bromide is used during airway management and anesthesia.
The ROCVIDEO trial compares remifentanil and Rocuronium Bromide for optimizing video laryngoscopy-assisted intubation in adults.
The emergency intubation trial studies a combined strategy that includes rocuronium, bag-mask ventilation before intubation, and a guide device for intubation to reduce early complications.
The morbid obesity study compares Rocuronium Bromide dosing based on ideal body weight versus real body weight to see which gives better intubation conditions.
In children, one study looks at the dose of sugammadex needed after Rocuronium Bromide, and another examines neuromuscular monitoring and how often reversal medicine is used.
Other studies look at recovery after anesthesia, including airway changes after reversal and the time needed to start breathing again.
Trial-by-trial summary
- 2024-515545-41-00: A Phase 3 study in infants having craniosynostosis surgery, looking at how anesthetic maintenance drugs affect rocuronium behavior and support safe reversal planning.
- 2025-521946-82-00: A Phase 2 dose-finding study in children under 2 years old, testing how much sugammadex is needed for full reversal after Rocuronium Bromide.
- NCT06564857: A large adult study of video laryngoscopy intubation, comparing Rocuronium Bromide with remifentanil for safety and first-pass success.
- 2024-519777-19-00: A Phase 3 study measuring airway size during residual muscle block and after reversal.
- 2025-520977-37-00: A withdrawn Phase 3 study in morbidly obese patients that planned to compare dosing by ideal versus real body weight.
- NCT05539391: A low-intervention emergency study in adults with respiratory distress, testing whether a combined intubation strategy lowers serious complications.
- 2024-510752-12-00: A Phase 3 stroke study comparing anesthesia approaches during mechanical thrombectomy, with time to recanalization as the main outcome.
- 2023-504204-28-00: A Phase 3 spine surgery study that includes Rocuronium Bromide as part of the anesthesia plan while measuring postoperative opioid use.
- NCT06331611: A Phase 3 pediatric anesthesia study examining neuromuscular monitoring and sugammadex use after Rocuronium Bromide.
- 2024-516415-24-03: A Phase 3 study in healthy volunteers looking at how fast spontaneous breathing returns after general anesthesia that includes Esmeron.
Patient-friendly terms
Neuromuscular monitoring means using a test to check how much muscle weakness is still present during anesthesia.
Decurarisation means reversal of muscle block, or helping muscle strength return after a muscle relaxant has been used.
Residual neuromuscular blockade means some muscle weakness remains after the operation or after the breathing tube is removed.
Airway cross-sectional area means the size of the breathing passage when viewed in a cross-section, which can help show whether the airway is narrowed.
First-pass intubation means the breathing tube is placed successfully on the first attempt.
Mechanical thrombectomy is a procedure used to remove a clot from an artery in the brain during stroke treatment.
Spontaneous breathing means breathing on your own without machine support.
Body mass index (BMI) is a number based on height and weight; in one trial, morbid obesity was defined as BMI 40 kg/m² or higher.