Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322657
• Other study ID #: 17-764
• Status: Completed
• Phase: Phase 4
• Start date: November 14, 2017
• Est. completion date: February 1, 2021

Study information

• Verified date: October 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Neuromuscular Blockade

Intervention

Drug:
• Neostigmine
Neostigmine injection
• Glycopyrrolate
Glycopyrrolate injection
• Sugammadex
Sugammadex injection

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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