At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Elective surgery under general anesthesia with sevoflurane maintenance
- ✓Received rocuronium for neuromuscular blockade
- ✓Received neostigmine for NMB reversal
- ✕Pregnancy or lactation
- ✕BMI ≥40
- ✕Severe renal impairment (CKD stage IV–V, GFR <30 ml/min/1.73 m²)
- ✕Severe hepatic impairment (Child-Pugh C)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Use of Sugammadex as Rescue Therapy Following Inadequate Reversal With Neostigmine
In Brief
A Phase 4 clinical trial evaluating Sugammadex and Placebo for Neuromuscular Blockade. Completed, enrolled 46 participants across 1 site.
Detailed Summary
Neuromuscular blocking agents (NMBAs) are commonly used in the practice of anesthesiology for skeletal muscle relaxation to facilitate tracheal intubation, mechanical ventilation, and to provide optimal surgical conditions. In order to prevent residual NMB, it is vital to adequately reverse any use of a non-depolarizing NMBA. This was historically done using an anticholinesterase such as neostigmine, which would increase the concentration of acetylcholine at the neuromuscular junction leading to the return of neuromuscular transmission. Unfortunately, there are disadvantages to the use of an anticholinesterase. It was in this context that sugammadex was found to be a valuable addition to the anesthesiologist's armamentarium. It is a modified γ-cyclodextrin that encapsulates the aminosteroid NMBAs rocuronium and vecuronium. This project is a double-blind randomized placebo-controlled dose-response trial that aims to determine the time taken to achieve adequate reversal comparing five doses of sugammadex as rescue therapy following inadequate reversal with neostigmine. The study team will recruit patients aged 18 years and above from the main operating room and outpatient surgery center at Grady Memorial Hospital who are undergoing elective surgery under general anesthesia, who has received NMB, received neostigmine for NMB reversal, and achieved a TOF count ≥ 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine was given. Those with a TOF count \< 3 twitches will drop out of the study as there are already specified doses of sugammadex for that level of NMB
Study Details
Timeline
Interventions
Sugammadex is a FDA-approved drug that is in routine clinical use for NMB reversal. Patients will be randomized to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated.
Normal saline will be used as placebo. The inclusion of a placebo group would allow us to examine if patients may recover spontaneously over that time without needing any sugammadex at all, and what parameters may predict that subset of patients. It will also improve the dose response modelling, in that randomization has been weighted so that patients who are least likely to need sugammadex (i.e. if they achieved a TOF count of 4 twitches without fade) are more likely to be in the placebo group or at the lowest dose of sugammadex that is being tested.