An observational study in Neuromuscular Blockade and Cholecystectomy, sponsored by Clínica Dávila. Not yet recruiting at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Clínica Dávila · Observational
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.
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.
98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 39 observational studies indexed under Delayed Emergence from Anesthesia.
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Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade at Clínica Dávila.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade. Simultaneous train-of-four (TOF) ratio measurements will be obtained at the end of surgery using acceleromyography and electromyography before administration of neuromuscular blockade reversal agents.
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.
Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios
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.
Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents
Mean Bias Between Acceleromyography and Electromyography TOF Ratios
Mean difference between the TOF ratio measured by acceleromyography and the TOF ratio measured by electromyography.
Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents
Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods
Upper and lower 95% limits of agreement for the difference between acceleromyography and electromyography TOF ratio measurements, calculated using Bland-Altman analysis.
Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents
Proportional Bias Between Acceleromyography and Electromyography TOF Ratios
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.
Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents
Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography
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.
Time frame: At the end of surgery, before administration of neuromuscular blockade reversal agents
Plan to share: No — Individual participant data (IPD) will not be shared. Only aggregate study results will be reported in scientific publications and presentations. Participant confidentiality will be protected in accordance with institutional policies and applicable ethical and regulatory requirements.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jan 2027, 5 months later.
Of 21 observational studies under Delayed Emergence from Anesthesia, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 32. This study's planned 5 months is below that.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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