Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClínica Dávila
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pre-existing neuromuscular disease.
Upper extremity abnormalities preventing neuromuscular monitoring.
Contraindications to neuromuscular monitoring.
Refusal or inability to provide informed consent.
Trial population
Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade at Clínica Dávila.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Simultaneous Acceleromyography and Electromyography Monitoring
Diagnostic testSimultaneous 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Adults Undergoing Elective Laparoscopic Cholecystectomy1 intervention
Trial outcomes
Primary outcomes
1
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 agentsSecondary outcomes
1
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 agents2
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 agents3
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 agents4
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 agentsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: