Background context: Amogammadex sodium has completed Phase I-III clinical studies in China for reversal of rocuronium-induced blockade. No clinical studies have yet been conducted for vecuronium-induced blockade. Therefore, this dose-finding study in an Australian population is intended to support further Phase III trials in European and American populations for reversal of both rocuronium- and vecuronium-induced neuromuscular blockade.
The goal of this clinical trial is to explore how well different doses of amogammadex sodium work to reverse neuromuscular blockade caused by rocuronium or vecuronium during surgery, and to learn about its safety. The main questions it aims to answer are:
* How quickly and effectively does amogammadex sodium restore muscle strength after moderate or deep neuromuscular blockade? * What medical problems do participants have when receiving amogammadex sodium?
Researchers will compare different doses of amogammadex sodium to see which works best. All participants will receive amogammadex sodium, but at different dose levels depending on when they join the study.
Participants will:
* Undergo screening up to 28 days before surgery to confirm eligibility * Receive amogammadex sodium at the end of surgery to reverse the effects of the muscle relaxant * Stay in the study for follow-up visits up to 7 days after surgery.
Participants should be willing to participate in the clinical study; the participants should fully understand and know this study and sign an informed consent form; the participants should be willing to follow and be able to complete all study procedures.
Male or female, 18 ≤ age ≤ 60.
Participant with the grade of American Society of Anaesthesiologists (ASA) physical status classification 1-2.
Participants who are scheduled to undergo approximately 2-hour surgery under TIVA with endotracheal intubation, and for whom vecuronium or rocuronium bromide is planned as the sole neuromuscular blocking agent.
Known or expected difficult intubation due to anatomical deformities
Known or suspected neuromuscular diseases, anatomical abnormality or neurological injury history that may affect neuromuscular transmission.
History or manifestation of disease that, in the opinion of the investigator, renders the participant unsuitable for the study, including but not limited to nervous system, cardiovascular, blood, lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic, and musculoskeletal disorders.
Participants with abnormal blood pressure not satisfactorily controlled (systolic blood pressure >160 mmHg or < 90 mmHg, diastolic blood pressure > 100 mmHg or < 60 mmHg). For subjects with systolic blood pressure ≥ 140 mmHg and ≤ 160 mmHg or diastolic blood pressure ≥ 90 mmHg and ≤ 100 mmHg and a history of well-controlled blood pressure, and no definite discomfort symptoms, the determination of clinical significance will be made at investigator discretion.
Parallel
Rocuronium (0.6mg/kg)
Druga single-dose intravenous bolus of 0.6 mg/kg rocuronium bromide，additional 0.1-0.2 mg/kg can be provided based on the required depth of neuromuscular blockade for surgery.
vecuronium bromide (0.1mg/kg)
DrugA single-dose intravenous bolus of 0.10 mg/kg vecuronium bromide， additional 0.015 mg/kg can be provided based on the required depth of neuromuscular blockade for surgery.
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Treatment groupsSee each treatment group below.
Efficacy Evaluation: The time from the start of the administration of amogammadex sodium to the recovery of the TOFr to 0.9 on day 1.
The TOFr value was measured using the TetraGraph neuromuscular transmission monitor during muscle relaxation monitoring. If The TOFr value is ≥ 0.9 for three consecutive times, the first time is recorded as the time of TOFr recovery to 0.9.
The Time from the start of administration of amogammadex sodium to recovery of the TOFr to 0.8 on day 1.
The TOFr value was measured using the TetraGraph neuromuscular transmission monitor during muscle relaxation monitoring. If The TOFr value is ≥ 0.8 for three consecutive times, the first time is recorded as the time of TOFr recovery to 0.8.
The Time from the start of administration of amogammadex sodium to recovery of the TOFr to 0.7 on day 1.
The TOFr value was measured using the TetraGraph neuromuscular transmission monitor during muscle relaxation monitoring. If The TOFr value is ≥ 0.7 for three consecutive times, the first time is recorded as the time of TOFr recovery to 0.7.
Incidence of Adverse Events (AEs)
Participant incidence of reported AEs as assessed by CTCAE v6.0 to determine the safety and tolerability of amogammadex sodium in participants undergoing elective surgery .
Click on the lead sponsor to view all of their trials.
Amckaus PTY LTD.
Lead sponsor
Novotech (Australia) Pty Limited
Collaborator
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