Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Blockade; Anesthesia

Treatments: Drug: Glycopyrrolate; Drug: Neostigmine; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT03322657

17-764

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years;
• American Society of Anesthesiologists (ASA) physical status 1-3;
• Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;
• General anesthesia.

Exclusion criteria

• Suspected difficult intubation;
• Neuromuscular disorder;
• Renal impairment creatinine ≥ 2 mg /dl;
• Hepatic dysfunction;
• History of malignant hyperthermia;
• Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;
• Perioperative respiratory infections and/or pneumonia;
• Intubated or unresponsive;
• Pregnancy or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 2 patient groups

Neostigmine with glycopyrrolate

Active Comparator group

Description:

Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery

Treatment:

Drug: Neostigmine

Drug: Glycopyrrolate

Sugammadex

Experimental group

Description:

Sugammadex 4 mg/kg at the end surgery

Treatment:

Drug: Sugammadex