Incidence and Clinical Implications of Residual Neuromuscular Blockade in Patients Planned for Post-Anesthesia Care Unit Admission: A Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- The primary outcome of this study was to investigate the incidence of postoperative residual neuromuscular blockade in patients identified as high risk during the preoperative assessment and to evaluate the associated clinical differences.
Study Overview
Brief Summary
Residual neuromuscular blockade (RNMB) remains an underrecognized postoperative safety concern associated with pulmonary complications, prolonged post-anesthesia care unit stay, and reduced patient satisfaction. Because conventional clinical tests are insufficiently sensitive and specific, current guidelines recommend quantitative neuromuscular monitoring to confirm adequate recovery, defined as a train-of-four ratio of ≥0.9.
This prospective observational study included adult patients aged 18-90 years with ASA physical status I-III who underwent elective surgery under general anesthesia with neuromuscular blocking agents. Demographic, clinical, anesthetic, surgical, and reversal-related variables were recorded. Postoperative neuromuscular recovery was quantitatively assessed at the adductor pollicis muscle using TOFscan® acceleromyography at the 10th postoperative minute. Patients were subsequently followed in either the PACU or surgical ward according to clinical indications, and postoperative adverse events were documented. The study aimed to evaluate the incidence and potential determinants of RNMB in accordance with contemporary neuromuscular monitoring guidelines.
Detailed Description
Residual neuromuscular blockade (RNMB) remains an important patient safety concern throughout the postoperative period and continues to be underrecognized by healthcare professionals. Current evidence suggests that RNMB is associated with an increased risk of postoperative pulmonary complications, prolonged length of stay in the post-anesthesia care unit (PACU), and reduced patient satisfaction.
Clinical assessment methods may include, but are not limited to, a 5-second head lift, sustained hand grip, eye opening, tongue protrusion, and the presence of spontaneous ventilation. Although these tests are commonly used by anesthesiologists, they lack sufficient sensitivity and specificity for the detection of RNMB.
The 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade provide recommendations regarding the use of quantitative neuromuscular monitoring in conjunction with pharmacological reversal to improve the recognition of RNMB and reduce its incidence. These guidelines recommend quantitative monitoring because it enables more reliable confirmation of a train-of-four ratio (TOFR) of ≥0.9 compared with qualitative assessment methods.
The use of quantitative neuromuscular monitoring to assess the depth of neuromuscular blockade may substantially reduce the risk of RNMB in patients undergoing general anesthesia. Several studies have also investigated whether combining pharmacological reversal of neuromuscular blockade with quantitative monitoring may further improve postoperative patient safety.
Patients scheduled for postoperative admission to the PACU commonly have significant comorbidities and higher American Society of Anesthesiologists physical status classifications. Therefore, postoperative RNMB may be particularly critical in this high-risk patient population. The present study was designed to evaluate postoperative neuromuscular recovery in accordance with current evidence-based guidelines.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III who underwent elective surgery under general anesthesia and received a neuromuscular blocking agent were included in the study.
Exclusion Criteria
- •Patients younger than 18 years or older than 90 years, those requiring postoperative invasive mechanical ventilation and transfer to the intensive care unit while intubated, patients undergoing emergency surgery, and those with a pre-existing neuromuscular disorder were excluded from the study.
Arms & Interventions
Patients scheduled for ward admission
Patients for whom postoperative admission to the post-anesthesia care unit (PACU) was not planned during the preoperative assessment
Patients scheduled for postoperative admission to the post-anesthesia care unit (PACU)
No study-specific intervention was planned for either group. Patients whose postoperative admission to the post-anesthesia care unit (PACU) had been planned on the basis of the preoperative assessment and the decision of the attending physician constituted the PACU group.
Outcomes
Primary Outcomes
The primary outcome of this study was to investigate the incidence of postoperative residual neuromuscular blockade in patients identified as high risk during the preoperative assessment and to evaluate the associated clinical differences.
Time Frame: Perioperative period, including follow-up until the 30th postoperative minute.
Patients scheduled for postoperative admission to the post-anesthesia care unit generally represent a population with a greater burden of comorbidities and higher American Society of Anesthesiologists physical status classifications. Therefore, postoperative residual neuromuscular blockade may be of greater clinical significance in this patient population. This study was designed to evaluate postoperative neuromuscular recovery in accordance with current guideline recommendations.
Secondary Outcomes
- seconder outcome(From the preoperative assessment through the intraoperative period and during the postoperative follow-up period for 24 hours.)
Investigators
Gizem Avci
Principal Investigator
Ankara Etlik City Hospital