Skip to content

Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery

Concordance Between Acceleromyography and Electromyography for Assessment of Neuromuscular Recovery at the End of Surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07739862
Enrollment
70
Registered
2026-07-31
Start date
2026-08-01
Completion date
2027-01-01
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy, Neuromuscular Blockade

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

DIAGNOSTIC_TESTSimultaneous 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.

Sponsors

Clínica Dávila
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Agreement Between Acceleromyography and Electromyography Train-of-Four RatiosAt the end of surgery, before administration of neuromuscular blockade reversal agentsAgreement 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

MeasureTime frameDescription
Mean Bias Between Acceleromyography and Electromyography TOF RatiosAt the end of surgery, before administration of neuromuscular blockade reversal agentsMean difference between the TOF ratio measured by acceleromyography and the TOF ratio measured by electromyography.
Ninety-Five Percent Limits of Agreement Between TOF Monitoring MethodsAt the end of surgery, before administration of neuromuscular blockade reversal agentsUpper 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 RatiosAt the end of surgery, before administration of neuromuscular blockade reversal agentsPresence 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 AcceleromyographyAt the end of surgery, before administration of neuromuscular blockade reversal agentsProportion 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

PRINCIPAL_INVESTIGATORDagoberto Ojeda, MD

Clínica Dávila

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026