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Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

NCT ID: NCT03322657

Last Updated: 2021-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-14

Study Completion Date

2021-02-01

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.

Conditions

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Neuromuscular Blockade Anesthesia

Keywords

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Sugammadex Neostigmine Reversal of neuromuscular block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Neostigmine injection

Glycopyrrolate

Intervention Type DRUG

Glycopyrrolate injection

Sugammadex

Sugammadex 4 mg/kg at the end surgery

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Sugammadex injection

Interventions

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Neostigmine

Neostigmine injection

Intervention Type DRUG

Glycopyrrolate

Glycopyrrolate injection

Intervention Type DRUG

Sugammadex

Sugammadex injection

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ehab Farag, MD

Ehab Farag, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Farag E, Rivas E, Bravo M, Hussain S, Argalious M, Khanna S, Seif J, Pu X, Mao G, Bain M, Elgabaly M, Esa WAS, Sessler DI. Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-Based Neurointerventional Procedures: A Randomized Trial. Anesth Analg. 2021 Jun 1;132(6):1666-1676. doi: 10.1213/ANE.0000000000005533.

Reference Type DERIVED
PMID: 34032663 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17-764

Identifier Type: -

Identifier Source: org_study_id