Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
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|ClinicalTrials.gov Identifier: NCT03322657|
Recruitment Status : Active, not recruiting
First Posted : October 26, 2017
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Blockade Anesthesia||Drug: Neostigmine Drug: Glycopyrrolate Drug: Sugammadex||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
|Actual Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 30, 2020|
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
Sugammadex 4 mg/kg at the end surgery
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322657
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|