Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial
8 сентября 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
150
Фаза
- Фаза 4
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Alexander Tran
- Номер телефона: 917-767-2701
- Электронная почта: alexander.tran2@mountsinai.org
Места учебы
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New York
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New York, New York, Соединенные Штаты, 10029
- Icahn School of Medicine at Mount Sinai
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Контакт:
- Alexander Tran
- Номер телефона: 917-767-2701
- Электронная почта: alexander.tran2@mountsinai.org
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Главный следователь:
- Benjamin Hyers, MD
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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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.
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Активный компаратор: 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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Sedation success
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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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:
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total sedation dose
Временное ограничение: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
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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.
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Time to peak sedation
Временное ограничение: From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.
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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).
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From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.
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Richmond Agitation-Sedation Scale (RASS)
Временное ограничение: Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.
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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).
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Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.
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Time to sedation recovery
Временное ограничение: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
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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).
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From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
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Anxiety scores
Временное ограничение: 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.
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Anxiety scores will be assessed via Likert scale 1-10.
A higher score indicates higher level of anxiety.
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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.
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Iowa Satisfaction with Anesthesia Scale (ISAS)
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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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.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Time for Neuraxial Placement
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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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.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Heart Rate
Временное ограничение: 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.
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The patient's heart rate (HR) will be assessed.
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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.
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Mean Blood Pressure
Временное ограничение: 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.
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The patient's mean blood pressure (MBP) will be assessed.
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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.
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Respiratory Rate
Временное ограничение: 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.
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The patient's respiratory rate (RR) will be assessed.
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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.
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Oxygen Saturation
Временное ограничение: 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.
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The patient's oxygen saturation (SpO2) will be assessed.
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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.
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Number of participants who experienced hypoxia
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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The presence of hypoxia will be accessed.
Hypoxia will be defined as oxygen saturation (SpO2) < 90%.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who experienced hypotension
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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The presence of hypotension will be accessed.
Hypotension is systolic blood pressure (SBP) < 80% of baseline.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who experienced tachycardia
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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The presence of tachycardia will be accessed.
Tachycardia will be heart rate (HR) > 100 bpm.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who experienced bradycardia
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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The presence of bradycardia will be accessed.
Bradycardia will be heart rate (HR) < 60 bpm.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who used vasoactive drugs (ephedrine, phenylephrine)
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Vasoactive drugs (ephedrine, phenylephrine) are used if a patient has hypotension refractory to the standard care of fluids and prophylactic phenylephrine.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who needed flumazenil
Временное ограничение: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Flumazenil is a reversal agent for remimazolam and used if the patient is clinically oversedated.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of fetal NICU admissions
Временное ограничение: Up to approximately 4 hours post-delivery.
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The number of fetal NICU admissions will be recorded.
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Up to approximately 4 hours post-delivery.
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Fetal APGAR scores
Временное ограничение: 1 minute and 5 minutes after infant birth.
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The APGAR score is a cumulative score ranging from 0 to 10.
A higher score indicates a better health outcome.
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1 minute and 5 minutes after infant birth.
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Umbilical artery/vein pH
Временное ограничение: Up to approximately 4 hours post-delivery.
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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.
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Up to approximately 4 hours post-delivery.
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Base excess
Временное ограничение: Up to approximately 4 hours post-delivery.
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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.
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Up to approximately 4 hours post-delivery.
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Benjamin Hyers, MD, Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
25 ноября 2026 г.
Первичное завершение (Оцененный)
1 мая 2028 г.
Завершение исследования (Оцененный)
1 мая 2028 г.
Даты регистрации исследования
Первый отправленный
11 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
11 июня 2026 г.
Первый опубликованный (Действительный)
16 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
9 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY-26-00500
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .