NCT03322657

Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.

Detailed description

Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU). Neostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects. Sugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks. Patients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.

Conditions

• Neuromuscular Blockade
• Anesthesia

Interventions

Type	Name	Description
DRUG	Neostigmine	Neostigmine injection
DRUG	Glycopyrrolate	Glycopyrrolate injection
DRUG	Sugammadex	Sugammadex injection

Timeline

• Start date: 2017-11-14
• Primary completion: 2020-12-31
• Completion: 2021-02-01
• First posted: 2017-10-26
• Last updated: 2021-11-16
• Results posted: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study