Cholecystectomy, Neuromuscular Blockade
Conditions
Keywords
Acceleromyography, Electromyography, Train-of-Four, TOF Ratio, Neuromuscular Monitoring, Residual Neuromuscular Blockade, General Anesthesia, Laparoscopic Cholecystectomy, Bland-Altman Analysis, Diagnostic Agreement
Brief summary
This prospective observational study aims to evaluate the agreement between acceleromyography and electromyography for measuring train-of-four (TOF) ratio at the end of surgery before reversal of neuromuscular blockade. Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade will undergo simultaneous TOF measurements using both monitoring methods. The study will assess the agreement between the two techniques, estimate measurement bias and limits of agreement, and determine the frequency of clinically relevant disagreement that could affect assessment of neuromuscular recovery and safe extubation.
Detailed description
Quantitative neuromuscular monitoring is recommended to reduce the incidence of residual neuromuscular blockade and its associated postoperative complications. Although electromyography is considered the current clinical reference method for objective neuromuscular monitoring, acceleromyography remains the most commonly used technique in routine clinical practice because of its availability, lower cost, and ease of use. However, acceleromyography may overestimate neuromuscular recovery, particularly when baseline normalization is not performed. This prospective observational diagnostic agreement study will enroll adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia requiring administration of non-depolarizing neuromuscular blocking agents. At the end of surgery, before administration of neuromuscular blockade reversal agents, simultaneous train-of-four (TOF) ratio measurements will be obtained using acceleromyography and electromyography. Acceleromyography will be performed according to routine clinical practice without baseline normalization, while electromyography will serve as the reference method. The primary objective is to evaluate the agreement between acceleromyography and electromyography measurements obtained at the end of surgery. Secondary objectives include estimating the mean bias between methods, calculating the 95% limits of agreement using Bland-Altman analysis, evaluating proportional bias, and determining the proportion of patients in whom acceleromyography indicates adequate neuromuscular recovery (TOF ≥0.9) while electromyography demonstrates residual neuromuscular blockade (TOF \<0.9). Demographic, clinical, and anesthetic variables will also be collected. Approximately 70 participants are expected to be enrolled.
Interventions
Simultaneous quantitative neuromuscular monitoring using acceleromyography and electromyography to measure the train-of-four (TOF) ratio at the end of surgery before administration of neuromuscular blockade reversal agents.
Sponsors
Study design
Eligibility
Inclusion criteria
* Adults aged 18 years or older. * Scheduled for elective laparoscopic cholecystectomy under general anesthesia. * Administration of non-depolarizing neuromuscular blocking agents. * Written informed consent provided.
Exclusion criteria
* Pre-existing neuromuscular disease. * Upper extremity abnormalities preventing neuromuscular monitoring. * Contraindications to neuromuscular monitoring. * Refusal or inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios | At the end of surgery, before administration of neuromuscular blockade reversal agents | Agreement between the train-of-four (TOF) ratios measured simultaneously by acceleromyography and electromyography at the end of surgery. Agreement between the two measurement methods will be evaluated using Bland-Altman analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Bias Between Acceleromyography and Electromyography TOF Ratios | At the end of surgery, before administration of neuromuscular blockade reversal agents | Mean difference between the TOF ratio measured by acceleromyography and the TOF ratio measured by electromyography. |
| Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods | At the end of surgery, before administration of neuromuscular blockade reversal agents | Upper and lower 95% limits of agreement for the difference between acceleromyography and electromyography TOF ratio measurements, calculated using Bland-Altman analysis. |
| Proportional Bias Between Acceleromyography and Electromyography TOF Ratios | At the end of surgery, before administration of neuromuscular blockade reversal agents | Presence and magnitude of proportional bias between the two monitoring methods, evaluated by assessing the relationship between the difference in TOF ratios and the mean TOF ratio obtained by acceleromyography and electromyography. |
| Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography | At the end of surgery, before administration of neuromuscular blockade reversal agents | Proportion of participants in whom acceleromyography indicates adequate neuromuscular recovery, defined as a TOF ratio greater than or equal to 0.90, while electromyography indicates residual neuromuscular blockade, defined as a TOF ratio below 0.90. |
Countries
Chile
Contacts
Clínica Dávila