Abstract
The high incidence of residual paralysis in the post-anesthesia care unit is a problem that needs evidence-based change in a large tertiary medical center. Side effects, including incomplete neuromuscular recovery, increase the length of stay and can occasion permanent brain damage or death due to respiratory complications. A guideline for assessment of this event and Sugammadex administration lacks at the unit. This project will develop and implement a protocol based on a review of current evidence on residual paralysis management, neuromuscular monitoring best practices, and effective reversal agents. The Stetler model will guide the implementation of the protocol at the unit. The key metrics for evaluating the effectiveness of the project will include compliance rates and post-implementation skill levels, and nurse satisfaction. Sustainability will be enhanced by key stakeholder involvement and presentation to senior leaders at the facility.
Residual paralysis is linked to postoperative complications and is characterized by weakness, respiratory failure, and hypoxia though it is not limited to these complications (Plaud, Debaene, Donati, & Marty, 2010). Other complications are associated with residual paralysis and have an unrecognized role in the neuromuscular block. It is a persistent issue in the post-anesthesia care unit (PACU) even after the administration of acetylcholinesterase inhibitors. Residual paralysis after emergence from anesthesia frequency is between 4-50% based on the diagnostic criteria, the administration of a reversal agent, and the type of non-depolarizing neuromuscular blocking drugs (NMBDs) as well as if there neuromuscular monitoring is done (Plaud et al., 2010). The phenomenon is clinically relevant since residual paralysis could lead to severe permanent brain damage and even death occasioned by oxygen desaturation, pulmonary collapse, muscle weakness, and acute respiratory failure.
Significance of the Issue
Residual paralysis after emergence anesthesia is clinically relevant since it is associated with oxygen desaturation, pulmonary collapse, muscle weakness, and acute respiratory that can lead to severe permanent brain damage or even death. The use of neuromuscular relaxation (anesthetic agents) facilitates endotracheal intubation, such that there is improved visualization and manipulation during the surgery and allows the optimization of the patient-ventilator interaction (González-Cárdenas, Salazar-Ramírez, & Coral-Sánchez, 2016). While there are considerable benefits of neuromuscular relaxation agents in facilitating successful surgery, they may lead to postoperative residue paralysis (Debaene et al., 2003; Plaud et al., 2010; Claudius, Garvey, & Viby-Mogensen, 2009). Although there have been extensive studies on residual paralysis, awareness of the clinical consequences is still not well established (Plaud et al., 2010). Nursing practices in preventing and treating residual paralysis post-emergence anesthesia are usually dictated by local practices and traditions rather than by evidence-based medicine. These practices include the use of reversal agents, neuromuscular monitoring, and the use of NMBDs (Plaud et al., 2010). Therefore, there is an urgent need to formulate a sound strategy to prevent, diagnose, and treat residual paralysis to avert the related postoperative complications.
This project will review extant studies on residual paralysis after emergence from anesthesia to identify agents that are currently available to accelerate neuromuscular recovery. This study will also review the practices that can be used to prevent and diagnose residual paralysis following the administration of neuromuscular blockers. The study also focuses on exploring the effectiveness of pharmacological reversal therapy based on the review studies. The aim of this project is to develop and implement a protocol based on a review of current evidence on residual paralysis management, neuromuscular monitoring best practices, and effective reversal agents that would lead to prevention, diagnosis, and treatment of residual paralysis in patients emerging from anesthesia.
A limited review of the literature was conducted to identify practice recommendations for residual paralysis management. Diverse studies, including systematic reviews and randomized clinical trials, were utilized, and thus, the strength of evidence guiding this project ranges between level I and V. Three prospective observational studies (level II evidence) examining the severity of neuromuscular blockade found that the incidences of residual paralysis in PACU range from 2 to 88% (Debaene et al., 2003; Donati, 2013; Fortier et al., 2015). Residual analysis persists and remains undetectable for several hours even after a muscle relaxant is administered. For this reason, Debaene et al. (2003) recommend measuring neuromuscular transmission quantitatively to diagnose residual paralysis. Effective detection of blockade by assessing neuromuscular function can reduce the incidence of this condition in PACU settings.
The analysis of systematic reviews provided level I evidence indicating that most cases of residual paralysis go unnoticed during the post-anesthesia recovery period, which exacerbates the risk for severe life-threatening conditions in PACU (Plaud et al., 2010; Naguib et al., 2010; Murphy & Brull, 2010). The incidence of residual paralysis particularly concerns older patients who present with impaired organ ability to clear medications and increased sensitivity in aspects of the duration and depth of the relaxation effects. Based on statistics, relaxation effects in elderly patients are linked to additional economic and healthcare burdens when it is compared to other age groups (González-Cárdenas et al., 2016). An analytical observational cohort study by González-Cárdenas et al. (2016) provided level IV evidence demonstrating that pharmacological reversal led to 89.4% and 100% success when Neostigmine and Sugammadex were used. This implies that pharmacological reversal therapies are highly effective in treating residual paralysis after emerging from anesthesia. The study established that residual paralysis reversal was more effective with Neostigmine than Sugammadex, with a 10% higher clinical latency (González-Cárdenas et al., 2016). However, relative to Neostigmine, Sugammadex had multiple benefits, including an intense blockade.
Varposhti et al. (2011), in an experimental study (level I evidence) involving 216 patients scheduled for elective surgery under general anesthesia, showed that more than two hours between administration of a single intubation dose of atracurium, an intermediate-acting non-depolarizing muscle relaxant, and arrival to the PACU could prevent residual paralysis. The findings of the study imply that a longer duration between the administrations of the single dose of atracurium can prevent residual paralysis after emerging from anesthesia. The train-of-four (TOF) ratio < 9 is indicative of neuromuscular blockade that must be evaluated even after administering a muscle relaxant (Varposhti et al., 2011). Qualitative tests lack adequate sensitivity to assess recovery after emergence; thus, quantitative assessment of the TOF ratio is needed after surgery to detect residual paralysis.
In a case report based on experiential evidence that is graded as level V, Sugammadex was shown to be effective in reducing recovery from neuromuscular blockade after residual paralyzing following general anesthesia (Green et al., 2017). In cases where neostigmine and glycopyrrolate did not completely reverse neuromuscular blockade following anesthesia, the study recommends the need to identify the optimal dose of Sugammadex that will reduce the time of recovery. The study has established that the incomplete recovery (residual paralysis), associated with the use of neostigmine and glycopyrrolate, can be prevented through the identification of the appropriate dose of Sugammadex such that the patient will not require postoperative ventilation. This drug was shown to decrease the time of recovery from residual paralysis after neostigmine administration. It prevents persistent neuromuscular blockage, allowing timely removal of endotracheal tubes and limiting the need for mechanical ventilation postoperatively.
Indeed, the use of a novel cyclodextrin was found to reverse rocuronium-induced NMB in doses of 16 mg/kg, indicating an alteration of Sugammadex dose could help in reversing residual paralysis in patients at various depths of NMB (Green et al., 2017). For this study, Green et al. (2017) demonstrated that the use of a dose of 2 mg/kg allowed for the optimal duration of neostigmine, leading to a significant recovery of patients with residual paralysis within 3 minutes of administration of the drug. A systematic review (Level I evidence) by Luo et al. (2018) found that neostigmine has some limitations, such as its limited ability to reverse extreme neuromuscular blockade and cardiovascular risks, especially in geriatric and pediatric patients. Therefore, appropriate administration of this drug (timing and dosage) is needed to reverse residual paralysis after emergence.
Theoretical Framework
To improve care in residual paralysis from anesthesia, this study will apply the Stetler model to utilize research in improving practice at PACU. The Stettler model will guide the review of selected research studies for their applicability and feasibility in clinical practice. The Stetler model will facilitate the implementation of the research findings in the clinical settings and recommend practice change. The model examines how evidence from research can be applied for a formal change in the organization and how individuals can apply evidence from research to improve critical thinking and reflective practice (Stetler, 2001). Therefore, the Stetler model will link research use and evidence-based practice. The aim of this project is to translate research evidence for appropriate assessment of residual paralysis and Sugammadex administration into a guideline for a PACU setting.
This theoretical framework is based on the assumption that a lack of knowledge regarding research use and evidence-based practice can impede an appropriate and effective use of research outcomes (Romp & Kiehl, 2009). Another assumption is that the healthcare organization may or may not be involved in an individual nurse’s use of research to improve practice. The framework consists of five phases, namely, preparation, validation, decision making (comparative evaluation), application (translation), and evaluation. Each of the five phases is designed to facilitate critical thinking during practice, utilize evidence, and mitigate human errors during the decision-making process (Stetler, 2001).
The Stetler model involves five steps that include preparation, validation, comparative evaluation, translation/application, and evaluation. In the adapted Stetler model, phase one of the models (preparation) was included. In this phase, the researcher purposed on identifying measurable outcomes from relevant articles that sought to prevent residual paralysis in patients emerging from anesthesia, improve diagnosis as well improve the management of residual paralysis in the post-anesthesia care unit. The articles could identify the enablers of improving patient care for patients with residual paralysis and identify the pitfalls of managing these patients. Such barriers to care for patients emerging from anesthesia and presenting with residual paralysis include the lack of early diagnosis of the condition, inadequate monitoring of the patient, and incomplete recovery due to inappropriate dosage. The purpose of phase I was to establish the primary rationale for consulting evidence supporting the practice change at a PACU setting. Poor outcomes and barriers to effective diagnosis and management of residual paralysis formed the basis for improving provider proficiency and adherence.
The second phase included in this study is validation, where each relevant article on the diagnosis and management of residual paralysis in the PACU is evaluated to identify whether there is sufficient evidence to support practice change. Current guidelines for residual paralysis diagnosis and management and clinic charts at the PACU unit will be reviewed to identify practice gaps and dosing guidelines in order to justify the change. The current evidence will also be evaluated for credibility and relevance to the setting, with specific best practices regarding Sugammadex dosing identified for use.
The third step in the adapted theory is the synthesis of the findings to determine the feasibility and desirability of the practice in improving patient care in residual paralysis post-anesthesia. All findings will be organized and congregated into a guideline using the Delphi procedure. Establishing research consensus through a comparative evaluation of different studies, determining the feasibility of the project, and collecting more data will be needed to provide the evidence base for the practice change.
The fourth phase is translating or applying the new knowledge or evidence synthesized from the literature review in the PACU setting. It is the culmination of the inquiry, whereby best practices in residual paralysis diagnosis, management, and dosage will be implemented to improve patient outcomes – reduced neuromuscular blockade in a postoperative unit. The plan for implementation will entail collaboration with PACU nurses, physicians, and anesthetists to promote adherence. Communicating the evidence to these stakeholders will help refine the guideline further.
The fifth step is the evaluation of the guideline a few weeks into its implementation at the unit. The key indicators of success to be measured include provider satisfaction, Sugammadex dosage adherence, and reduced severity or incidence of neuromuscular blockade in patients. Ongoing assessment of the guideline will inform further refinement of the guideline. Further literature searches will provide new evidence to improve the intervention by building on the initial successes.
Organization and Individual Culture and Barriers to Translation
The study setting was the PACU of a large metropolitan tertiary medical center. Some institutional factors hinder the diagnosis and treatment of residual paralysis at the unit. Sugammadex is not being used in this practice setting due to perceived high costs of reversal per case. There is also a general view that this treatment may not be clinically needed, as the drug is not included in the pharmacy’s formulary. The facility also lacks a protocol for the administration of a reversal agent to guide practice at the unit. The development and implementation of clinical practice guidelines with evidence-based recommendations for Sugammadex administration can reduce the incidence of this preventable event.
At the individual level, staff attitudes and norms prevent the routine clinical application of best practices at the unit. PACU nurses do not assess residual paralysis as standard care for safe emergence, increasing the risk of respiratory complications such as pharyngeal dysfunction and reduced inspiratory airflow (Saager et al., 2019). The current practice of neuromuscular monitoring is also inadequate, which increases the incidence of this event. Education on residual paralysis can help PACU nurses use technology to monitor neuromuscular activity as a routine practice.
Potential barriers to the translation of the recommendations identified from literature into practice relate to perceived cost, education, and technical challenges at the unit. The perception that incorporating Sugammadex into the treatment protocol will increase the budget must be addressed. Compared to Neostigmine, Sugammadex can reverse any level of neuromuscular blockade within 2-3 minutes (Cammu, 2018). Thus, the performance of this novel agent (time saved) can be a basis for introducing it at the facility as a cost-effective reversal agent.
The lack of education and problem awareness is another barrier that should be addressed for best practices to be adopted in the unit. Anesthesia providers and the PACU nurses will undergo a four-week training on an evidence-based protocol (visual tool) for the assessment and treatment of residual paralysis. Increased awareness of this preventable event can lead to early diagnosis, adequate patient monitoring, and correct dosage administration. Technical challenges limiting the use of technology for quantitative neuromuscular monitoring after emergence will be addressed through in-person education.
Evaluation Plan
Two weeks into the training, nurse compliance level with the protocol will be measured to determine the success of the project. The specific aspects of being evaluated include the frequency with which staff nurses use the assessment tool at the end of a shift, administer an appropriate dosage of the reversal agent (Sugammadex), and monitor neuromuscular function quantitatively using available technology (Murphy, 2018). The results of the performance audit will be compared to baseline scores to determine skill improvement. Another metric of the effectiveness of the project is the improvement in the post-implementation incidence of residual paralysis (after the four-week education) at the unit compared to the pre-implementation rate.
Increased mention of this event in rounding tools will be a useful measure of problem awareness among PACU nurses. After four weeks, the charts will be audited to determine if nurses adhere to correct assessment, monitoring, and documentation of residual paralysis before administering Sugammadex. A post-intervention survey will be conducted to assess nurse skills and satisfaction with the protocol compared to baseline data. Participating PACU nurses will indicate improvements in understanding of residue paralysis, its symptoms, assessment, and management after the training. Further, their satisfaction with the education and skills acquired will indicate the effectiveness of this project. Using a reliable survey will enhance the accuracy of the evaluation plan. Cronbach’s Alpha will be used to empirically evaluate the internal consistency and reliability of the multi-scale items included this tool, and metrics with a value > 0.5 will be combined to give a final composite score (Polit & Beck, 2017). These items will constitute a true measure of the PACU nurses’ satisfaction with the protocol – an indicator of the project’s success.
Plans for Sustainability
An effective plan will be needed to maintain the evidence-based protocol for residue paralysis assessment and treatment in the unit. First, key stakeholders with a major influence on clinical protocols and guidelines at the unit, including the PACU manager and educator, will be engaged in the initial implementation of the change project to serve as long-term advocates for the initiative. The unit manager will also monitor nurse compliance with the evidence-based protocol. Sustainability will also be achieved by presenting the post-implementation outcomes to the clinical nurse leader and hospital administrators. The presentation will emphasize the project’s impact and value to the facility’s mission to secure the resources needed to sustain the initiative. According to Trautman et al. (2018), visible involvement of the senior leadership is critical in maintaining projects that have clear contributions to quality improvement. Therefore, key leaders and staff will be engaged from the onset to gain trust and support for the initiative beyond the first few months.
References
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