Table of Contents
- Trial overview
- Who is being studied
- Trial phases and study types
- Main endpoints being measured
- Main study focuses
- Trial-by-trial summary
- Patient-friendly terms
Trial overview
These clinical trials study Rocuronium Bromide in real patient care settings, mainly during anesthesia, intubation, and surgery.[1][2][3]
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.[1][4][5]
Who is being studied
The target populations are very different across the trials.[1][2][3]
- Infants having surgery for craniosynostosis, which is an early fusion of skull bones.[1]
- Children under 2 years old who need rocuronium and then reversal with sugammadex.[2]
- Adults having tracheal intubation with video laryngoscopy, which uses a camera to help place a breathing tube.[3]
- Patients with residual neuromuscular blockade after extubation, meaning some muscle weakness remains after the breathing tube is removed.[4]
- Morbidly obese patients, defined in the trial as BMI at least 40 kg/m².[5]
- Adults needing emergency tracheal intubation because of respiratory distress.[6]
- People with acute ischemic stroke undergoing mechanical thrombectomy, a procedure to remove a clot and restore blood flow.[7]
- Patients having lumbar arthrodesis, which is surgery to fuse bones in the lower spine.[8]
- Pediatric patients scheduled for elective surgery under general anesthesia.[9]
- Healthy volunteers in a study of recovery from general anesthesia.[10]
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.[1][4][5][7][8][9][10]
One study is Phase 2 and focuses on dose determination in children under 2 years of age.[2]
Two studies are described as Low Intervention, meaning the research is focused on care strategies rather than testing a new drug plan alone.[3][6]
Main endpoints being measured
The trials measure different endpoints, which are the main results the researchers want to learn from the study.[1]
- How much sevoflurane or propofol changes the properties of rocuronium at different doses in infants.[1]
- The total dose of sugammadex needed to achieve complete decurarisation, meaning full reversal of muscle block, in children under 2 years.[2]
- Failed first-pass intubation, meaning the breathing tube is not placed successfully on the first try.[3]
- Airway cross-sectional area during residual neuromuscular blockade and after reversal.[4]
- Excellent intubation conditions in morbidly obese patients when Rocuronium Bromide is dosed by ideal body weight or real body weight.[5]
- Severe intubation-related complications in the first hour after emergency intubation.[6]
- Time from hospital arrival to arterial recanalization, which means reopening the blocked artery in stroke treatment.[7]
- Postoperative opioid use after lumbar arthrodesis with and without erector spinae plane block.[8]
- How often sugammadex is used at the end of anesthesia in pediatric surgery.[9]
- Time to the return of spontaneous breathing after general anesthesia in healthy volunteers.[10]
Main study focuses
Several trials focus on how Rocuronium Bromide is used during airway management and anesthesia.[3][5][6]
The ROCVIDEO trial compares remifentanil and Rocuronium Bromide for optimizing video laryngoscopy-assisted intubation in adults.[3]
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.[6]
The morbid obesity study compares Rocuronium Bromide dosing based on ideal body weight versus real body weight to see which gives better intubation conditions.[5]
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.[2][9]
Other studies look at recovery after anesthesia, including airway changes after reversal and the time needed to start breathing again.[4][10]
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.[1]
- 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.[2]
- NCT06564857: A large adult study of video laryngoscopy intubation, comparing Rocuronium Bromide with remifentanil for safety and first-pass success.[3]
- 2024-519777-19-00: A Phase 3 study measuring airway size during residual muscle block and after reversal.[4]
- 2025-520977-37-00: A withdrawn Phase 3 study in morbidly obese patients that planned to compare dosing by ideal versus real body weight.[5]
- NCT05539391: A low-intervention emergency study in adults with respiratory distress, testing whether a combined intubation strategy lowers serious complications.[6]
- 2024-510752-12-00: A Phase 3 stroke study comparing anesthesia approaches during mechanical thrombectomy, with time to recanalization as the main outcome.[7]
- 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.[8]
- NCT06331611: A Phase 3 pediatric anesthesia study examining neuromuscular monitoring and sugammadex use after Rocuronium Bromide.[9]
- 2024-516415-24-03: A Phase 3 study in healthy volunteers looking at how fast spontaneous breathing returns after general anesthesia that includes Esmeron.[10]
Patient-friendly terms
Neuromuscular monitoring means using a test to check how much muscle weakness is still present during anesthesia.[2][9]
Decurarisation means reversal of muscle block, or helping muscle strength return after a muscle relaxant has been used.[2]
Residual neuromuscular blockade means some muscle weakness remains after the operation or after the breathing tube is removed.[4]
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.[4]
First-pass intubation means the breathing tube is placed successfully on the first attempt.[3]
Mechanical thrombectomy is a procedure used to remove a clot from an artery in the brain during stroke treatment.[7]
Spontaneous breathing means breathing on your own without machine support.[10]
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.[5]
