Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Remimazolam, Dexmedetomidine.
- Кому может быть актуально
- Состояния в реестре: Pregnant People, Anxiety. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Remimazolam Versus Dexmedetomidine for Procedural Sedation During Neuraxial Anesthesia Placement For Scheduled Cesarean Delivery
Обзор
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.
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.
Вмешательства
- Препарат 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 - Препарат 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 t
Первичные конечные точки
- Sedation success [Срок оценки: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.]
Вторичные конечные точки (12)
- Total sedation dose [Срок оценки: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.]
- Time to peak sedation [Срок оценки: From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.]
- Richmond Agitation-Sedation Scale (RASS) [Срок оценки: Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.]
- Time to sedation recovery [Срок оценки: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.]
- Anxiety scores [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.]
Критерии участия
Критерии включения
- Pregnant patient scheduled for cesarean delivery
- ≥ 18 years old
- ≥ 37 weeks gestational age
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Icahn School of Medicine at Mount Sinai — New York
Идентификаторы
NCT: NCT07651956 · STUDY-26-00500