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Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monitoring (ROC-IONM)

30 maja 2026 zaktualizowane przez: Nguyen Toan Thang, Bach Mai Hospital

A Randomized Controlled Trial Comparing Low-Dose Rocuronium Maintenance Versus Discontinuation After Induction on Motor Evoked Potential Quality During Spine Surgery With Intraoperative Neurophysiological Monitoring

This randomized controlled trial will compare two strategies for rocuronium use during general anesthesia for spine surgery with intraoperative neurophysiological monitoring. Participants undergoing spine surgery under general anesthesia with motor evoked potential and/or somatosensory evoked potential monitoring will be randomized to either low-dose rocuronium maintenance targeting a train-of-four ratio of 0.60 to less than 0.90, or no rocuronium maintenance after induction.

The main objective is to compare the effects of these two strategies on the quality of intraoperative neurophysiological monitoring, especially motor evoked potential signals. Secondary objectives include comparing surgical field conditions, unwanted patient movement, emergence and extubation times, early respiratory events, and new postoperative neurological deficits.

The study will be conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam. The planned sample size is 62 participants, with 31 participants in each group.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Intraoperative neurophysiological monitoring is commonly used during complex spine surgery to help detect early neurological injury. Motor evoked potentials are particularly sensitive to neuromuscular blockade. Avoiding maintenance neuromuscular blockade may improve motor evoked potential signal quality, but may increase the risk of unwanted patient movement and suboptimal surgical field conditions. Conversely, low-dose rocuronium maintenance may improve surgical conditions, but may reduce motor evoked potential amplitude if neuromuscular blockade is excessive.

This trial will evaluate whether low-dose rocuronium maintenance, titrated by quantitative neuromuscular monitoring, can preserve intraoperative neurophysiological monitoring quality while improving surgical field conditions compared with discontinuation of rocuronium after induction.

All participants will receive standardized total intravenous anesthesia with propofol-based maintenance, bispectral index monitoring, quantitative train-of-four monitoring, and intraoperative neurophysiological monitoring. Rocuronium will be administered for tracheal intubation in both groups. In the low-dose maintenance group, rocuronium will be titrated to maintain a train-of-four ratio from 0.60 to less than 0.90. In the no-maintenance group, no additional rocuronium will be given after induction unless predefined safety rescue is required.

The primary outcome will be intraoperative motor evoked potential signal quality, including mean motor evoked potential amplitude. Secondary outcomes will include successful motor evoked potential recording, motor evoked potential warning events, somatosensory evoked potential stability, surgical field condition, unwanted patient movement, time to emergence, time to extubation, early postoperative respiratory events, and new postoperative neurological deficits.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

62

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

- 1. Patients aged 18 years or older. 2. Patients scheduled for spine surgery under general anesthesia. 3. Patients undergoing spine surgery with intraoperative neurophysiological monitoring, including motor evoked potentials and/or somatosensory evoked potentials.

4. Patients who agree to participate in the study and provide written informed consent.

Exclusion Criteria:

  • 1. Pre-existing central or peripheral neurological disease that may affect intraoperative neurophysiological monitoring, such as quadriplegia, persistent sensory disorder, sequelae of stroke, or polyneuropathy.

    2. History of epilepsy or electroencephalographic disorder. 3. Use of neuropsychiatric drugs, strong sedatives, or drugs affecting neuromuscular or neurological conduction within 48 hours before surgery.

    4. Decompensated cardiovascular disease or severe respiratory disease that may affect emergence or anesthetic drug metabolism.

    5. Contraindication to intraoperative neurophysiological monitoring. 6. Contraindication to rocuronium. 7. Refusal to participate or withdrawal of consent at any time..

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Low-Dose Rocuronium Maintenance
Participants in this group will receive rocuronium for tracheal intubation followed by low-dose rocuronium maintenance during surgery. Rocuronium will be titrated using quantitative train-of-four monitoring to maintain a train-of-four ratio from 0.60 to less than 0.90. All participants will receive standardized total intravenous anesthesia and intraoperative neurophysiological monitoring.
Lek: Low-Dose Rocuronium Maintenance
Rocuronium will be administered for tracheal intubation and then maintained at a low dose during surgery. The infusion will be titrated according to quantitative train-of-four monitoring to maintain a train-of-four ratio from 0.60 to less than 0.90.
Aktywny komparator: No Rocuronium Maintenance After Induction
Participants in this group will receive rocuronium for tracheal intubation only. No maintenance rocuronium will be administered after induction. Additional rocuronium may be given only as predefined safety rescue if clinically necessary. All participants will receive standardized total intravenous anesthesia and intraoperative neurophysiological monitoring.
Lek: Rocuronium
Rocuronium will be administered only for tracheal intubation during induction of anesthesia. No maintenance rocuronium will be administered after induction, except for predefined safety rescue if clinically necessary.
Inne nazwy:
  • Rocuronium for Intubation Only

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Intraoperative Motor Evoked Potential Amplitude
Ramy czasowe: From baseline intraoperative neurophysiological monitoring after patient positioning to the final intraoperative neurophysiological monitoring recording before wound closure
Mean intraoperative motor evoked potential amplitude, measured in microvolts, recorded from predefined target muscles during spine surgery. The mean of three consecutive technically acceptable responses will be used at standardized intraoperative time points after stabilization of anesthesia and physiologic parameters.
From baseline intraoperative neurophysiological monitoring after patient positioning to the final intraoperative neurophysiological monitoring recording before wound closure

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Successful Motor Evoked Potential Recording
Ramy czasowe: During surgery
Proportion of participants with successful intraoperative motor evoked potential recording from at least one predefined target muscle.
During surgery
Motor Evoked Potential Warning Events
Ramy czasowe: During surgery
Number of intraoperative motor evoked potential warning events, defined as a decrease of 50 percent or more in amplitude from baseline lasting more than 5 minutes and not attributable to surgical manipulation after correction of physiologic and technical factors.
During surgery
Surgical Field Condition
Ramy czasowe: During surgery
Surgical field condition assessed using the Leiden-Surgical Rating Scale, ranging from 1 to 5, with higher scores indicating better surgical conditions.
During surgery
Unwanted Patient Movement
Ramy czasowe: During surgery
Occurrence and number of unwanted patient movement events that affect surgical manipulation or require anesthetic or neuromuscular blockade adjustment.
During surgery
Time to Extubation
Ramy czasowe: From discontinuation of maintenance anesthesia to tracheal extubation
Time from discontinuation of maintenance anesthetic infusion to safe tracheal extubation, measured in minutes.
From discontinuation of maintenance anesthesia to tracheal extubation
New Postoperative Neurological Deficit
Ramy czasowe: Post-anesthesia care unit and 24 to 48 hours after surgery
Occurrence of new postoperative motor or sensory neurological deficit assessed in the post-anesthesia care unit and within 24 to 48 hours after surgery.
Post-anesthesia care unit and 24 to 48 hours after surgery
Somatosensory Evoked Potential Stability
Ramy czasowe: During surgery
Proportion of intraoperative monitoring time without significant somatosensory evoked potential changes, defined as latency increase of 10 percent or more or amplitude decrease of 50 percent or more from baseline lasting more than 5 minutes and not attributable to surgical manipulation.
During surgery
Time to Emergence
Ramy czasowe: From discontinuation of maintenance anesthesia to eye opening on verbal command
Time from discontinuation of maintenance anesthetic infusion to eye opening on verbal command, measured in minutes.
From discontinuation of maintenance anesthesia to eye opening on verbal command
Early Postoperative Respiratory Events
Ramy czasowe: During emergence and within 60 minutes after arrival in the post-anesthesia care unit
Occurrence of early respiratory events, including oxygen desaturation below 92 percent, laryngospasm, bronchospasm, sputum obstruction, or delayed extubation due to respiratory muscle weakness.
During emergence and within 60 minutes after arrival in the post-anesthesia care unit

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Bach Mai Hospital

Współpracownicy

Hanoi Medical University

Śledczy

  • Główny śledczy: Toan Thang Nguyen, MD, PhD, Associate Professor, Hanoi Medical University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

30 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 maja 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HMU-BMH-ROC-IONM-2025-01
  • 225/BM-HDDD (Inny identyfikator: Ethics Committee of Bach Mai Hospital)
  • 6513/QD-DHYHN (Inny identyfikator: Hanoi Medical University)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be publicly shared because the study involves sensitive clinical and perioperative data. Data are protected by privacy and ethical restrictions. De-identified aggregate data may be available from the corresponding author upon reasonable request and with approval from the relevant ethics committee.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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