Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Simultaneous Acceleromyography and Electromyography Monitoring.
- Who it may be relevant to
- Registry conditions: Neuromuscular Blockade, Cholecystectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Concordance Between Acceleromyography and Electromyography for Assessment of Neuromuscular Recovery at the End of Surgery
Overview
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
- Diagnostic test Simultaneous Acceleromyography and Electromyography Monitoring
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.
Primary outcome measures
- Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios [Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents]
Secondary outcome measures (4)
- Mean Bias Between Acceleromyography and Electromyography TOF Ratios [Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents]
- Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods [Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents]
- Proportional Bias Between Acceleromyography and Electromyography TOF Ratios [Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents]
- Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography [Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Chile · 1 center
- Clínica Dávila — Santiago
Identifiers
NCT: NCT07739862 · CD2026/16