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Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

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ClinicalTrials.gov Identifier: NCT03322657
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ehab Farag, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Anesthesia Drug: Neostigmine Drug: Glycopyrrolate Drug: Sugammadex Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Neostigmine with glycopyrrolate
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
Neostigmine injection

Drug: Glycopyrrolate
Glycopyrrolate injection

Experimental: Sugammadex
Sugammadex 4 mg/kg at the end surgery
Drug: Sugammadex
Sugammadex injection




Primary Outcome Measures :
  1. Time in minutes to reach train of four (TOF) ratio ≥ 0.9 after the administration of reversal agent [ Time Frame: 90 minutes after endotracheal extubation ]
    The TOF ratio twitches ≥ 0.9 will be measured in continuous manner every 12 seconds from the administration of the reversal drug. The TOF ratio will be measured by acceleromyography of the force developed in the adductor pollicis muscle using the TOF scan.


Secondary Outcome Measures :
  1. The time for extubation after administration of reversal agents [ Time Frame: Up to 4 hours after administration of reversal agents ]
    Time from administration of reversal agent to tracheal extubation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322657


Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ehab Farag, MD    216-444-7550    farage@ccf.org   
Contact: Roberta J Johnson    216-444-9950    johnsor13@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic

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Responsible Party: Ehab Farag, Ehab Farag, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03322657     History of Changes
Other Study ID Numbers: 17-764
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ehab Farag, The Cleveland Clinic:
Sugammadex
Neostigmine
Reversal of neuromuscular block
Additional relevant MeSH terms:
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Glycopyrrolate
Rocuronium
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists