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NCT Number: NCT07739862

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Dávila

Santiago, Santiago Metropolitan, 8431657, Chile

Location contact

Alejandra Rivera, MsC Epidemiology

CONTACT

[email protected]

930363776

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simultaneous Acceleromyography and Electromyography Monitoring

Diagnostic Test

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 outcomes

  1. Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios

    Time frame: 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 outcomes

  1. Mean Bias Between Acceleromyography and Electromyography TOF Ratios

    Time frame: 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.

  2. Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods

    Time frame: 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.

  3. Proportional Bias Between Acceleromyography and Electromyography TOF Ratios

    Time frame: 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.

  4. Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clínica Dávila

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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