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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 8431657
- Clínica Dávila
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Kontakt:
- Alejandra Rivera, MsC Epidemiology
- Telefonnummer: 930363776
- E-Mail: alejandra.rivera@davila.cl
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Adults Undergoing Elective Laparoscopic Cholecystectomy
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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios
Zeitfenster: At the end of surgery, before administration of neuromuscular blockade reversal agents
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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.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Mean Bias Between Acceleromyography and Electromyography TOF Ratios
Zeitfenster: At the end of surgery, before administration of neuromuscular blockade reversal agents
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Mean difference between the TOF ratio measured by acceleromyography and the TOF ratio measured by electromyography.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods
Zeitfenster: At the end of surgery, before administration of neuromuscular blockade reversal agents
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Upper and lower 95% limits of agreement for the difference between acceleromyography and electromyography TOF ratio measurements, calculated using Bland-Altman analysis.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Proportional Bias Between Acceleromyography and Electromyography TOF Ratios
Zeitfenster: At the end of surgery, before administration of neuromuscular blockade reversal agents
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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.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography
Zeitfenster: At the end of surgery, before administration of neuromuscular blockade reversal agents
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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.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Dagoberto Ojeda, MD, Clínica Dávila
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CD2026/16
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