Clinical trial NCT03322657: Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
Official title: Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Anesthesia
Keywords: Sugammadex
Neostigmine
Reversal of neuromuscular block
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent
timeFrame: within 90 minutes after endotracheal extubation
measure: TOF Ratio at 90 Min
timeFrame: at 90 minutes after the administration of the reversal agent
Secondary outcomes:
measure: The Time for Extubation After Administration of Reversal Agents
timeFrame: Up to 4 hours after administration of reversal agents
measure: Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s
timeFrame: from baseline to 90 minutes after the administration of the reversal agent
measure: Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s
timeFrame: from baseline to 90 minutes after the administration of reversal agent
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
citation: Farag E, Rivas E, Bravo M, Hussain S, Argalious M, Khanna S, Seif J, Pu X, Mao G, Bain M, Elgabaly M, Esa WAS, Sessler DI. Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-Based Neurointerventional Procedures: A Randomized Trial. Anesth Analg. 2021 Jun 1;132(6):1666-1676. doi: 10.1213/ANE.0000000000005533.