Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

NCT03322657 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-764
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade; Anesthesia

Keywords

Sugammadex; Neostigmine; Reversal of neuromuscular block

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• The Time for Extubation After Administration of Reversal Agents

  Up to 4 hours after administration of reversal agents

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

  from baseline to 90 minutes after the administration of the reversal agent

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

  from baseline to 90 minutes after the administration of reversal agent

Study Arms (2)

Neostigmine with glycopyrrolate

ACTIVE COMPARATOR

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; Drug: Glycopyrrolate

Sugammadex

EXPERIMENTAL

Sugammadex 4 mg/kg at the end surgery

Drug: Sugammadex

Interventions

Neostigmine DRUG

Neostigmine injection

Neostigmine with glycopyrrolate

Glycopyrrolate DRUG

Glycopyrrolate injection

Neostigmine with glycopyrrolate

Sugammadex DRUG

Sugammadex injection

Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 34032663 DERIVED

MeSH Terms

Interventions

Neostigmine; Glycopyrrolate; Sugammadex

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Ehab Farag
• Organization: Cleveland Clinic Foundation

FARAGE@ccf.org

216 444-7550

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ehab Farag, M.D.

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 26, 2017
• Study Start: November 14, 2017
• Primary Completion: December 31, 2020
• Study Completion: February 1, 2021
• Last Updated: November 16, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-10

Locations

US (1)