Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neuromuscular Blockade, Anesthesia

Intervention / Treatment
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* Drug: Neostigmine
* Drug: Glycopyrrolate
* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine with glycopyrrolate<br>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 | Drug: Neostigmine<br>* Neostigmine injection<br>Drug: Glycopyrrolate<br>* Glycopyrrolate injection<br>|
| Experimental: Sugammadex<br>Sugammadex 4 mg/kg at the end surgery | Drug: Sugammadex<br>* Sugammadex injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent | The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent. | within 90 minutes after endotracheal extubation | 
| TOF Ratio at 90 Min | TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board. Our primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis. | at 90 minutes after the administration of the reversal agent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Time for Extubation After Administration of Reversal Agents | Time from administration of reversal agent to tracheal extubation | Up to 4 hours after administration of reversal agents | 
| Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s | The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction. | from baseline to 90 minutes after the administration of the reversal agent | 
| Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s | The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction. | from baseline to 90 minutes after the administration of reversal agent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugammadex, Neostigmine, Reversal of neuromuscular block