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Completed

NCT Number: NCT03322657

Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neostigmine

Drug

Neostigmine injection

Glycopyrrolate

Drug

Glycopyrrolate injection

Sugammadex

Drug

Sugammadex injection

Primary outcomes

  1. Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent

    Time frame: within 90 minutes after endotracheal extubation

    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.

  2. TOF Ratio at 90 Min

    Time frame: at 90 minutes after the administration of the reversal agent

    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.

Secondary outcomes

  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

  2. Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s

    Time frame: from baseline to 90 minutes after the administration of the reversal agent

    The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.

  3. Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s

    Time frame: from baseline to 90 minutes after the administration of reversal agent

    The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 26, 2017
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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