Caregiver Education for Paralysis Management

(ED-AWARENES II Trial)

Recruiting at 3 trial locations

Overseen By Brian Fuller, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Neuromuscular blockers

Disqualifiers: Neurologic injury, Death, Transfer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

3090 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how educating caregivers about certain medicines can enhance care for patients on mechanical ventilation in the emergency department. It specifically focuses on using succinylcholine, a fast-acting medication, instead of rocuronium, which lasts longer and may increase the risk of AWP, a condition that can cause muscle weakness. The researchers aim to determine if this education and change in practice can improve patient outcomes. Individuals who have been mechanically ventilated and are receiving neuromuscular blockers (paralytic medications) in the emergency department might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to important research that could improve emergency care practices.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves the use of neuromuscular blockers, it's best to discuss your current medications with the trial team to ensure there are no interactions.

What prior data suggests that this educational intervention is safe for mechanically ventilated ED patients?

Research has shown that succinylcholine, the muscle relaxant used in the trial, has been safely used in emergency rooms for over 40 years. Succinylcholine is preferred because it acts quickly and its effects last only about five minutes, reducing the risk of complications compared to longer-lasting options like rocuronium.

Educational programs aimed at improving the use of muscle relaxants have succeeded in other studies. For instance, training sessions have enhanced nurses' knowledge and safe handling of these drugs. These programs have also increased the use of monitoring techniques that help prevent complications.

Overall, the treatment under study appears well-tolerated based on past use and supportive educational efforts. The sources provided have not noted any specific side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of an educational initiative on the use of neuromuscular blockers in emergency departments. Unlike current practices that often rely on standard neuromuscular blockers, this approach aims to improve the use of shorter-acting neuromuscular blockers, which could potentially enhance patient outcomes. By educating caregivers, this trial seeks to optimize paralysis management, potentially leading to quicker recovery times and more efficient use of medical resources. This represents a significant shift in focus from simply administering treatments to empowering caregivers with crucial knowledge, which could transform standard care practices in emergency settings.

What evidence suggests that this trial's treatments could be effective for paralysis management?

Research has shown that educational programs can significantly improve the safe use of muscle-relaxing medications during surgery or ventilator use. Studies indicate that training helps nurses understand and administer these drugs safely. One study found that education increased the use of train-of-four monitoring, a technique that checks muscle response and improves patient outcomes. In this trial, participants in the "After group" will receive neuromuscular blockers following an educational initiative designed to improve the use of shorter-acting neuromuscular blockers. This program aims to reduce risks and enhance care by teaching caregivers how to use these medications more effectively. ^{1 2 3 4 5}

Who Is on the Research Team?

Brian Fuller, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

The ED-AWARENESS-2 Trial is for adults over 18 who are receiving mechanical ventilation via an endotracheal tube in the emergency department (ED) and have been treated with neuromuscular blockers. It excludes those with neurological injuries that prevent assessment of awareness during paralysis, patients transferred out, or those who die before extubation.

Inclusion Criteria

I am on a breathing machine through a tube in my windpipe.

I have been treated with a muscle relaxant for intubation.

Exclusion Criteria

Transfer to another hospital from the ED

I have a brain condition that makes it hard to assess my pain.

The participant has passed away before being removed from a breathing tube.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Not specified

Control Phase

Patients receive usual care with standard neuromuscular blockers; this phase is entirely observational.

6 months

Transition Phase

Implementation of the intervention with education of ED clinicians on AWP prevention and study objectives.

2 months

Intervention Phase

Patients receive succinylcholine as the default neuromuscular blocker, with passive and active alerts to support the intervention.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for PTSD symptoms, depression, anxiety, and quality of life.

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Education
• Standard neuromuscular blocker practices

Trial Overview

This trial tests whether educating ED clinicians on the use of succinylcholine—a short-acting neuromuscular blocker—over rocuronium can reduce risks associated with prolonged paralysis. The study uses a stepped wedge design across five sites to compare standard practices against this educational intervention.

How Is the Trial Designed?

Group I: After group Experimental Treatment 1 Intervention

Mechanically ventilated emergency department patients receiving neuromuscular blockers after an educational initiative aimed at improving use of shorter acting neuromuscular blocker practices in the ED.

Group II: Before group Active Control 1 Intervention

Mechanically ventilated emergency department patients receiving standard neuromuscular blockers prior to an educational initiative on the importance of ED-based targeted shorter acting neuromuscular blocker.

Standard neuromuscular blocker practices is already approved in United States, European Union for the following indications:

Approved in United States as Succinylcholine for:

• Facilitation of endotracheal intubation
• Initiation of mechanical ventilation for acute respiratory failure

Approved in United States as Rocuronium for:

• Facilitation of endotracheal intubation
• Initiation of mechanical ventilation for acute respiratory failure

Approved in European Union as Succinylcholine for:

• Facilitation of endotracheal intubation
• Initiation of mechanical ventilation for acute respiratory failure

Approved in European Union as Rocuronium for:

• Facilitation of endotracheal intubation
• Initiation of mechanical ventilation for acute respiratory failure

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 105 children undergoing elective day-case tonsillectomy, using a reduced dose of rocuronium (0.45 mg/kg) significantly shortened the recovery time from neuromuscular block to 7.3 minutes, compared to 15.9 minutes for vecuronium and 16.0 minutes for standard rocuronium doses.

The reduced-dose rocuronium maintained acceptable intubating conditions while minimizing operating room time by up to 37%, and it was associated with low rates of postoperative nausea and vomiting, indicating its efficacy and safety for short surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced-dose rocuronium for day-case tonsillectomy in children where volatile anaesthetics are not used: operating room time saving. Bartolek, D., Jakobović, J., Bartolek, F., et al.[2018]

Pregabalin 150mg significantly reduces the incidence and severity of myalgia after succinylcholine use in patients undergoing elective spine surgery, compared to a placebo group.

While pregabalin did not significantly reduce the overall incidence of muscle fasciculations, it was associated with fewer patients experiencing moderate to severe fasciculations, indicating a potential benefit in managing side effects of succinylcholine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic use of pregabalin for prevention of succinylcholine-induced fasciculation and myalgia: a randomized, double-blinded, placebo-controlled study. Srivastava, VK., Agrawal, S., Nimbhorkar, VK., et al.[2017]

In a study involving 13 healthy adults, high doses of sugammadex (up to 96 mg/kg) were generally well tolerated, with mild adverse events occurring more frequently at higher doses, but no serious adverse events reported.

Pharmacokinetic analysis showed that sugammadex was eliminated in a dose-linear manner, with 90-93% of the administered dose excreted unchanged in urine within 48 hours, indicating effective renal clearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability and pharmacokinetics of sugammadex using single high doses (up to 96 mg/kg) in healthy adult subjects: a randomized, double-blind, crossover, placebo-controlled, single-centre study. Peeters, PA., van den Heuvel, MW., van Heumen, E., et al.[2022]

Rocuronium is a nondepolarizing neuromuscular blocking agent that acts quickly, making it ideal for situations requiring rapid intubation, and it does not produce active metabolites, enhancing its safety profile.

It has been successfully used in various high-risk surgical settings, including emergency surgeries and cesarean deliveries, due to its hemodynamic stability and predictable reversibility of effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rocuronium]. Alvarez-Gómez, JA.[2018]

Sugammadex has been shown to safely and rapidly reverse profound neuromuscular block caused by rocuronium and vecuronium, which is crucial for maintaining safe anesthesia practices.

The use of sugammadex allows for better control over neuromuscular block during surgery, potentially changing clinical practices by enabling quick recovery of muscle power after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implications of new neuromuscular concepts and agents: so long, neostigmine! So long, sux! Lee, C., Katz, RL.[2022]

Elderly patients (average age 76.9 years) experience a significantly slower recovery from rocuronium-induced muscle paralysis when treated with low-dose sugammadex compared to nonelderly patients (average age 53.7 years), with recovery rates of 1.89%/min versus 3.45%/min, respectively.

The incidence of recurarization (return of muscle paralysis) is notably higher in elderly patients at 35%, compared to just 5% in nonelderly patients, indicating a greater risk of complications when using low-dose sugammadex in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences of Recovery from Rocuronium-induced Deep Paralysis in Response to Small Doses of Sugammadex between Elderly and Nonelderly Patients. Muramatsu, T., Isono, S., Ishikawa, T., et al.[2019]

Sugammadex reverses profound neuromuscular block caused by vecuronium significantly faster than neostigmine, with recovery times of 4.5 minutes compared to 66.2 minutes, based on a study of 83 patients.

The study found no serious drug-related adverse events in either treatment group, indicating that sugammadex is a safe option for reversing neuromuscular block during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia: sugammadex versus neostigmine. Lemmens, HJ., El-Orbany, MI., Berry, J., et al.[2021]

A patient who received an accidental high dose of sugammadex (40 mg/kg) experienced a rapid and effective reversal of a profound neuromuscular block caused by rocuronium (1.2 mg/kg).

No adverse events or safety concerns were reported, highlighting the safety profile of sugammadex even at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversal of rocuronium-induced (1.2 mg kg-1) profound neuromuscular block by accidental high dose of sugammadex (40 mg kg-1). Molina, AL., de Boer, HD., Klimek, M., et al.[2022]

A survey of 1296 Brazilian anesthesiologists revealed that rocuronium, atracurium, and cisatracurium are the most commonly used neuromuscular blockers, but less than 15% frequently use neuromuscular function monitors to assess recovery from muscle relaxants.

The study highlighted significant safety concerns, as many anesthesiologists rely on clinical criteria alone to determine recovery, leading to complications like residual curarization and prolonged blockade, with some cases even resulting in reported deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of neuromuscular blockers in Brazil. Locks, Gde F., Cavalcanti, IL., Duarte, NM., et al.[2022]

In a study of 55 patients (27 with liver cirrhosis and 28 controls), sugammadex was found to significantly reduce recovery time from rocuronium-induced neuromuscular block compared to neostigmine, with recovery times of 3.1 minutes for cirrhosis patients and 2.6 minutes for controls after sugammadex administration.

Sugammadex provided an 80% reduction in recovery time compared to neostigmine, and there were no incidents of postoperative re-curarization with either antagonist, indicating its safety and efficacy in patients with liver cirrhosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sugammadex antagonism of rocuronium-induced neuromuscular blockade in patients with liver cirrhosis undergoing liver resection: a randomized controlled study. Abdulatif, M., Lotfy, M., Mousa, M., et al.[2019]

In a study of 150 adults undergoing outpatient surgery, using rocuronium for neuromuscular blockade followed by sugammadex for reversal resulted in a significantly faster recovery time (1.8 minutes) compared to succinylcholine, which took about 10.8 minutes to recover.

Both methods had similar health outcomes and adverse event rates, indicating that rocuronium-sugammadex is a safe and effective alternative for outpatient procedures without extending recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial. Soto, R., Jahr, JS., Pavlin, J., et al.[2018]

Tubocurarine, a key neuromuscular blocking agent derived from curare, was instrumental in understanding acetylcholine's role in muscle contraction, but it has unwanted side effects that led to the development of newer alternatives.

Current nondepolarising neuromuscular blockers, like rocuronium, offer rapid onset for intubation and may have their effects quickly reversed by a novel antagonist, enhancing safety and efficacy during surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular block. Bowman, WC.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12281960/

Effectiveness of an educational module on nurses ...

The implementing educational module had positive large effect size on nurses' performance (Knowledge and practice) regarding safe administration ...

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withpower.com

withpower.com/trial/caregiver-education-for-paralysis-management-22bb5

Caregiver Education for Paralysis Management

What data supports the effectiveness of the treatment Education, Educational Intervention, Coping Education, Mental Health Education, Standard neuromuscular ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10878712/

Improving Neuromuscular Monitoring Through Education ...

We assessed the association between education-based interventions, the frequency of train-of-four (TOF) monitoring, and postoperative outcomes.

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researchgate.net/publication/393913875_Effectiveness_of_an_educational_module_on_nurses'_performance_regarding_safe_administration_and_adverse_effects_of_neuromuscular_blocking_agents_in_critically_ill_patients

(PDF) Effectiveness of an educational module on nurses ...

Conclusion The implementing educational module had positive large effect size on nurses' performance (Knowledge and practice) regarding safe ...

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digitalcommons.wustl.edu

digitalcommons.wustl.edu/cgi/viewcontent.cgi?article=1003&context=dnp_golfarb

Education Aimed to Increase Train-of-Four Ratio Use

Purpose: The purpose of the project was to determine if an education intervention founded on evidence-based neuromuscular monitoring leads to ...