In short
Sugammadex sodium is a chemically synthesised medicine given by injection into a vein to reverse the effect of certain muscle relaxants used during general anaesthesia.
Key points
- Sugammadex sodium is a chemically synthesised medicine given by intravenous injection.
- One Phase 3 trial is studying sugammadex for fast awakening from general anaesthesia in healthy volunteers.
- The trial plans to enrol 10 participants and is currently authorised.
- The main measurement is time to the return of spontaneous breathing.
- Sugammadex is used in clinical practice to reverse rocuronium or vecuronium muscle relaxation at the end of surgery.
What is sugammadex sodium?
Sugammadex sodium is a chemically synthesised substance classified under the ATC code V03AB35, a group of medicines described as "all other therapeutic products". It belongs to a class of medicines known as selective relaxant binding agents.
How does sugammadex sodium work?
During many operations, patients receive medicines called neuromuscular blocking agents, such as rocuronium or vecuronium, to relax their muscles so that surgeons can work safely and a breathing tube can be placed. Sugammadex works by binding tightly to these muscle relaxants in the bloodstream, forming a complex that inactivates them. This allows the muscles to regain their strength quickly once the operation is finished. The NHS formulary for Cambridgeshire and Peterborough describes sugammadex as a medicine for the "reversal of rocuronium or vecuronium muscle relaxation at the end of surgery or after failed intubation where residual paralysis remains".
Which conditions is it used or studied for?
- Reversal of neuromuscular blockade after surgery — sugammadex is used in clinical practice to reverse the muscle relaxation caused by rocuronium or vecuronium at the end of an operation, so that the patient can breathe on their own again.
- General anaesthesia — the registered Phase 3 trial is studying how quickly sugammadex can help healthy volunteers wake up from general anaesthesia and start breathing spontaneously.
- Failed intubation — the NHS formulary also lists sugammadex for situations where placing a breathing tube has failed and residual muscle paralysis remains.
How is sugammadex sodium given?
Sugammadex is given as a solution for injection directly into a vein, meaning intravenous administration. The authorised product in the Netherlands is a 100 mg/ml solution for injection. In the United Kingdom, the dm+d browser lists Sugammadex 200 mg/2 ml solution for injection vials, which is the same concentration, supplied by hameln pharma Ltd. The electronic medicines compendium also lists a Sugammadex 100 mg/mL solution for injection from Glenmark Pharmaceuticals Europe Ltd, with a Summary of Product Characteristics and a Patient Information Leaflet available.
What do the clinical trials show?
One clinical trial of sugammadex sodium is listed in the EU Clinical Trials Information System (CTIS). It is a Phase 3, interventional, observational intervention study called "Fast awakening from general anesthesia, an observational intervention study in healthy volunteers". The trial is currently authorised, meaning it has received regulatory approval to proceed, and plans to enrol 10 healthy volunteers.
The trial investigates the duration and efficiency of rapid sequence emergence from general anaesthesia. Its primary outcome is the time to the return of spontaneous breathing, meaning how long it takes for a participant to start breathing on their own after the anaesthetic medicines are stopped. In the trial, sugammadex is given at a dose of 16 mg per kilogram of body weight by intravenous administration. The study also uses several other medicines as part of the anaesthesia procedure: naloxone, flumazenil (Anexate), remimazolam, sufentanil and rocuronium (Esmeron).
What side effects are known?
The supplementary sources provided do not contain a specific list of side effects for sugammadex sodium. The electronic medicines compendium entry includes a Patient Information Leaflet for the Glenmark product, which would normally describe possible side effects, but the content provided here does not include that information.