Fast Reversal Of Effects Of Muscle Relaxants In General Anesthesia
Schering-Plough announced that sugammadex, a novel experimental muscle relaxant reversal agent, reversed moderate (shallow) rocuronium- and vecuronium-induced muscle relaxation considerably faster than the current standard of care in reversal agents.
Muscle relaxants play several critical roles in general anesthesia: facilitating intubation (the insertion of a tube to assist a patient with breathing during surgery); improving surgical conditions; and reducing the risk of complications during surgery. Reversal agents are given to stop the effects of muscle relaxants, allowing patients to breathe on their own again. Current reversal agents have limitations with regard to their effectiveness and are associated with undesirable side effects. The availability of a reversal agent that works quickly to reverse the muscle relaxant effects of general anesthesia would potentially offer anesthesiologists a greater level of control.
Results from a pooled analysis of Phase II and III clinical trial data showed that sugammadex reversed the effects of shallow rocuronium-induced muscle relaxation during general anesthesia in just under two minutes (median time to reversal), over nine times faster than neostigmine, and almost 20 times faster than placebo. Findings from another pooled analysis of Phase II and III data show that sugammadex reversed the effects of shallow vecuronium-induced muscle relaxation during general anesthesia in just over two minutes (median time to reversal), about eight times faster than neostigmine, and over 30 times faster than placebo.
"By not using reversal agents, or by using agents that work slowly, patient recovery from surgery is prolonged," said Professor Manfred Blobner from the Klinik fur Anasthesiologie der Technischen Universitat Munchen, Germany. "These data reinforce our belief that sugammadex has the potential to change the way anesthesia is practiced by offering us a tool that appears safe, tolerable and very effective in controlling and quickly reversing the effects of muscle relaxation."
Findings presented reinforce the tolerability of sugammadex as a reversal agent for both rocuronium- and vecuronium-induced muscle relaxation during anesthesia. In a pooled analysis of 640 patients or healthy volunteers given rocuronium or vecuronium, the proportion of patients with more than one adverse event was similar in patients given sugammadex as compared to placebo (68 percent vs. 72 percent, respectively.) Adverse events occurring in at least 2 percent of sugammadex subjects and at least twice as frequently as in placebo subjects included anesthetic complications and cough. Most adverse events were mild to moderate in intensity. In total, 5.8 percent of sugammadex and 4.3 percent of placebo subjects experienced at least one serious adverse event.