- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07661810
Patient-controlled Remimazolam Sedation Under Spinal Anesthesia
Patient-controlled Remimazolam Sedation During Primary Hip Arthroplasty Under Spinal Anesthesia: an Open-Label Randomized Controlled Trial
The goal of this clinical trial is to compare the efficacy of patient-controlled sedation (PCS) versus clinician-controlled sedation (CCS) using remimazolam in adult patients undergoing primary hip arthroplasty under spinal anesthesia.
The main questions it aims to answer are:
- Does patient-controlled sedation significantly reduce the total consumption of remimazolam compared to clinician-controlled sedation?
- Are there differences in secondary outcomes, such as sedation depth , sedation-related adverse events, frequency of airway interventions, and patient/surgeon satisfaction?
Researchers will compare the PCS group to the CCS group to see if the patient-controlled method leads to a reduction in total remimazolam consumption while maintaining effective sedation.
Participants will:
- Be randomly assigned to either the PCS group or the CCS group.
- In the PCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute. If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval.
- In the CCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h. The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Seokha Yoo, M.D., Ph.D.
- Номер телефона: +82-2-2072-2467
- Электронная почта: muroki85@snu.ac.kr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Patients aged 19 to 70 years with an ASA (American Society of Anesthesiologists) physical status of I or II who are undergoing primary hip arthroplasty under spinal anesthesia.
Exclusion Criteria:
- Refusal to participate in the study
- Patients with contraindications to spinal anesthesia
- Patients who do not consent to intraoperative sedation
- Patients with contraindications to remimazolam
- Patients with a history of allergy or hypersensitivity to remimazolam
- Patients with a baseline MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score of 4 or lower
- Pregnant women
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Patient-controlled sedation
Patient-controlled remimazolam sedation
|
Patients will receive an initial 0.05 mg/kg remimazolam dose over 1 minute.
If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval.
|
|
Активный компаратор: Clinician-controlled sedation
Clinician-controlled remimazolam sedation
|
Patients will receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h.
The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Total remimazolam consumption
Временное ограничение: From start to end of anesthesia (the estimated period is up to 6 hours)
|
Weight- and time-adjusted total remimazolam consumption (mg/kg/h)
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score
Временное ограничение: Day before surgery
|
Range: 20-80 (lower values mean a higher anxious state)
|
Day before surgery
|
|
Preoperative mAPAIS
Временное ограничение: Day before surgery
|
Day before surgery
|
|
|
Baseline quality of recovery (QOR-15-K) score
Временное ограничение: Day before surgery
|
range:0-150 (a higher value means a better quality of recovery)
|
Day before surgery
|
|
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1
Временное ограничение: 30 minutes before admission to operation room
|
Range: 20-80 (lower values mean a higher anxious state)
|
30 minutes before admission to operation room
|
|
Intraoperative depth of sedation
Временное ограничение: From start to end of anesthesia (the estimated period is up to 6 hours)
|
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
Frequency of rescue sedative administration
Временное ограничение: From start to end of anesthesia (the estimated period is up to 6 hours)
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
|
Incidence of sedation-related adverse events
Временное ограничение: From start to end of anesthesia (the estimated period is up to 6 hours)
|
Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS) criteria
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
Incidence of respiratory depression
Временное ограничение: From start to end of anesthesia (the estimated period is up to 6 hours)
|
Peripheral oxygen saturation < 95% or apnea > 30 s.
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
Frequency of airway interventions
Временное ограничение: From start to end of anesthesia (the estimated period is up to 6 hours)
|
From start to end of anesthesia (the estimated period is up to 6 hours)
|
|
|
Length of stay in the post-anesthesia care unit (PACU)
Временное ограничение: During the day of surgery, an average of 1 hour
|
Duration of the post-anesthetic care unit stay
|
During the day of surgery, an average of 1 hour
|
|
Patient satisfaction score with sedation
Временное ограничение: Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours)
|
How satisfied the patient was with sedation during surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied)
|
Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours)
|
|
Surgeon satisfaction score
Временное ограничение: Postoperative period/within 1 hour after surgery
|
How satisfied the surgeon was with the patient sedation during the surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied)
|
Postoperative period/within 1 hour after surgery
|
|
Quality of postoperative recovery (QOR-15K) score
Временное ограничение: at postoperative 24 hours
|
range:0-150 (a higher value means a better quality of recovery)
|
at postoperative 24 hours
|
Соавторы и исследователи
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2602-001-1716
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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