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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
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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
- Numer telefonu: 930363776
- E-mail: alejandra.rivera@davila.cl
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Mean Bias Between Acceleromyography and Electromyography TOF Ratios
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Dagoberto Ojeda, MD, Clínica Dávila
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CD2026/16
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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