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Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial

11 czerwca 2026 zaktualizowane przez: Benjamin Hyers, Icahn School of Medicine at Mount Sinai

Remimazolam Versus Dexmedetomidine for Procedural Sedation During Neuraxial Anesthesia Placement For Scheduled Cesarean Delivery

Patients presenting for a scheduled cesarean delivery who require a neuraxial anesthetic will be randomized to receive intravenous remimazolam or dexmedetomidine for procedural sedation during the placement of their spinal or epidural anesthesia.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

After obtaining consent, women presenting for scheduled cesarean delivery on the labor floor at Mount Sinai Hospital will be randomized into two groups to receive either remimazolam or dexmedetomidine. Baseline maternal demographic data, vital signs, and anxiety scores will be obtained. Prior to the placement of the spinal or epidural anesthesia, the unblinded clinical team will administer weight-based intravenous boluses of the assigned study medication, titrated to a target Richmond Agitation-Sedation Scale (RASS) score of -1 to -2. Maternal anxiety scores and vital signs will be continuously monitored at 5-minute intervals throughout the neuraxial placement procedure. Following the completion of the cesarean delivery, a blinded research member will administer a brief survey in the post-anesthesia care unit (PACU) to evaluate patient satisfaction and memory preservation.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Faza 4

Kontakty i lokalizacje

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

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • New York
      • New York, New York, Stany Zjednoczone, 10029
        • Icahn School of Medicine at Mount Sinai
        • Kontakt:
        • Główny śledczy:
          • Benjamin Hyers, MD

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:

  • Pregnant patient scheduled for cesarean delivery
  • ≥ 18 years old
  • ≥ 37 weeks gestational age

Exclusion Criteria:

  • Pregnant patients < 18 years old
  • Pregnant patients < 37 weeks gestational age
  • Has known hypersensitivity to benzodiazepines or dexmedetomidine
  • Has history of chronic benzodiazepine use or misuse

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: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Remimazolam
Participants randomized to this arm will receive intravenous remimazolam for procedural sedation prior to and during the placement of neuraxial anesthesia (spinal or epidural) for their scheduled cesarean delivery. Dosing will be titrated by an unblinded anesthesiologist to achieve a light target sedation level.
Lek: Remimazolam
Administered via multiple weight-based intravenous boluses of 0.03 mg/kg over 1-2 minutes. Boluses are titrated sequentially until the patient reaches a target Richmond Agitation-Sedation Scale (RASS) score of -1 to -2. Once the target sedation window is initially achieved, the clinical anesthesiologist will ask the patient if they desire additional anxiolysis; additional boluses will be given only upon explicit patient request. Administration terminates immediately upon successful placement of the neuraxial block.
Aktywny komparator: Dexmedetomidine
Participants randomized to this arm will receive intravenous dexmedetomidine for procedural sedation prior to and during the placement of neuraxial anesthesia (spinal or epidural) for their scheduled cesarean delivery. Dosing will be titrated by an unblinded anesthesiologist to achieve a light target sedation level.
Lek: Dexmedetomidine
Administered via multiple weight-based intravenous boluses of 0.1 μg/kg over 1-2 minutes. Boluses are titrated sequentially until the patient reaches a target Richmond Agitation-Sedation Scale (RASS) score of -1 to -2. Once the target sedation window is initially achieved, the clinical anesthesiologist will ask the patient if they desire additional anxiolysis; additional boluses will be given only upon explicit patient request. Administration terminates immediately upon successful placement of the neuraxial block.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Sedation success
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.

This will be a composite primary outcome that is patient focused with values "Yes" or "No." To achieve a "Yes" for sedation success, all the following components must be met:

  • Satisfaction of anxiolysis rated as ≥ 2 on a 9-point scale (where -4 = Completely Dissatisfied, 0 = Neutral, and +4 = Completely Satisfied)
  • Preserved memory of the birth
  • No vital sign changes during the neuraxial placement, defined as hypotension (SBP < 80% of baseline), hypertension (SBP > 120% of baseline), bradycardia (HR < 60 bpm), tachycardia (HR > 100 bpm), respiratory depression (RR < 12 breaths/min), hypoxia (SpO2 < 90%). Baseline is defined as pre-op vitals taken in the PACU.
  • Would get the medication again
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Total sedation dose
Ramy czasowe: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.

The total sedation dose used will be recorded for remimazolam in mg and mg/kg and dexmedetomidine in μg and μg/kg.

(The Richmond Agitation-Sedation Scale (RASS) scale score of 0 indicates that the participant is alert and calm.)
From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
Time to peak sedation
Ramy czasowe: From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.
The time to peak sedation will be defined as the time from start of sedation to highest Richmond Agitation-Sedation Scale (RASS) sedation score recorded. The Richmond Agitation-Sedation Scale (RASS) scale will be scored: 0 = alert and calm; -1 = drowsy (not fully alert, sustained (> 10 s) awareness with eye contact to voice); -2 = light sedation (awakens briefly (< 10 s) with eye contact to voice); -3 = moderate sedation (movement but no eye contact to voice); -4 = deep sedation (no response to voice, but eye opens or movement to physical stimulation); and -5 = unarousable (no response to voice or physical stimulation).
From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.
Richmond Agitation-Sedation Scale (RASS)
Ramy czasowe: Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.
The participant's sedation score will be assessed using the Richmond Agitation-Sedation Scale (RASS) scale. A RASS score of 0 = alert and calm; -1 = drowsy (not fully alert, sustained (> 10 s) awareness with eye contact to voice); -2 = light sedation (awakens briefly (< 10 s) with eye contact to voice); -3 = moderate sedation (movement but no eye contact to voice); -4 = deep sedation (no response to voice, but eye opens or movement to physical stimulation); and -5 = unarousable (no response to voice or physical stimulation).
Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.
Time to sedation recovery
Ramy czasowe: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
The time to sedation recovery, which is the time between last minute of peak sedation (RASS -1 to -2) to baseline sedation (RASS 0), will be recorded. A Richmond Agitation-Sedation Scale (RASS) score of 0 = alert and calm; -1 = drowsy (not fully alert, sustained (> 10 s) awareness with eye contact to voice); -2 = light sedation (awakens briefly (< 10 s) with eye contact to voice); -3 = moderate sedation (movement but no eye contact to voice); -4 = deep sedation (no response to voice, but eye opens or movement to physical stimulation); and -5 = unarousable (no response to voice or physical stimulation).
From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
Anxiety scores
Ramy czasowe: From the initiation of the study drug at baseline, 1 minute, 5 minutes, 10 minutes, 15 minutes, 20 minutes until neuraxial completion, up to 20 minutes.
Anxiety scores will be assessed via Likert scale 1-10. A higher score indicates higher level of anxiety.
From the initiation of the study drug at baseline, 1 minute, 5 minutes, 10 minutes, 15 minutes, 20 minutes until neuraxial completion, up to 20 minutes.
Iowa Satisfaction with Anesthesia Scale (ISAS)
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Patient satisfaction will be assessed using a short survey given in the PACU after the cesarean delivery using the Iowa Satisfaction with Anesthesia Scale (ISAS). ISAS is scored as a mean of responses to 11 statements (e.g., "I felt pain," "I was satisfied with my anesthetic care"), yielding a single composite number. Each statement is measured from a range of -3 (not satisfied) to +3 (satisfied). A higher score indicates a higher patient satisfaction.
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Time for Neuraxial Placement
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The time for neuraxial placement, which is the total time it takes for the anesthesiologist to complete placement of the neuraxial for the patient before cesarean delivery, will be recorded.
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Heart Rate
Ramy czasowe: Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The patient's heart rate (HR) will be assessed.
Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Mean Blood Pressure
Ramy czasowe: Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The patient's mean blood pressure (MBP) will be assessed.
Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Respiratory Rate
Ramy czasowe: Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The patient's respiratory rate (RR) will be assessed.
Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Oxygen Saturation
Ramy czasowe: Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The patient's oxygen saturation (SpO2) will be assessed.
Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who experienced hypoxia
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The presence of hypoxia will be accessed. Hypoxia will be defined as oxygen saturation (SpO2) < 90%.
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who experienced hypotension
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The presence of hypotension will be accessed. Hypotension is systolic blood pressure (SBP) < 80% of baseline.
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who experienced tachycardia
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The presence of tachycardia will be accessed. Tachycardia will be heart rate (HR) > 100 bpm.
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who experienced bradycardia
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
The presence of bradycardia will be accessed. Bradycardia will be heart rate (HR) < 60 bpm.
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who used vasoactive drugs (ephedrine, phenylephrine)
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Vasoactive drugs (ephedrine, phenylephrine) are used if a patient has hypotension refractory to the standard care of fluids and prophylactic phenylephrine.
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who needed flumazenil
Ramy czasowe: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Flumazenil is a reversal agent for remimazolam and used if the patient is clinically oversedated.
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of fetal NICU admissions
Ramy czasowe: Up to approximately 4 hours post-delivery.
The number of fetal NICU admissions will be recorded.
Up to approximately 4 hours post-delivery.
Fetal APGAR scores
Ramy czasowe: 1 minute and 5 minutes after infant birth.
The APGAR score is a cumulative score ranging from 0 to 10. A higher score indicates a better health outcome.
1 minute and 5 minutes after infant birth.
Umbilical artery/vein pH
Ramy czasowe: Up to approximately 4 hours post-delivery.
This is the pH of the umbilical artery and vein. Umbilical cord blood pH is a measure of the hydrogen ion concentration in the blood obtained from the umbilical artery and/or umbilical vein at birth. The pH scale is continuous, with a lower pH indicating greater acidemia. A lower pH may reflect increased fetal exposure to intrapartum hypoxia.
Up to approximately 4 hours post-delivery.
Base excess
Ramy czasowe: Up to approximately 4 hours post-delivery.
Base excess in umbilical cord blood is a continuous measure reported in mmol/L (or mEq/L). A higher (less negative) base excess indicates more normal neonatal acid-base status, while a lower (more negative) base excess indicates greater metabolic acidosis, reflecting fetal oxygen deficit during labor and delivery.
Up to approximately 4 hours post-delivery.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Icahn School of Medicine at Mount Sinai

Śledczy

  • Główny śledczy: Benjamin Hyers, MD, Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine

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 maja 2028

Ukończenie studiów (Szacowany)

1 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

11 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY-26-00500

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

The IRB-approved informed consent document signed by participants explicitly states that the research team will never use or share personal information, study data, or samples for future research, even if all identifiers are removed. The consent terms strictly mandate that data will only be used to complete this specific study and will subsequently be destroyed.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

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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