Идёт набор NCT07334418

Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study

Без фазы С лечением Cesarean Section Delivery; Trauma

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: General anesthetic, Intravenous anesthetic.
Кому может быть актуально: Состояния в реестре: Cesarean Section, Delivery; Trauma. 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

EAGLET-CS Pilot: Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study

Обзор

Some patients who undergo cesarean section under spinal or epidural anesthesia can experience severe pain. Some patients who experience this kind of pain can experience symptoms of post-traumatic stress disorder (PTSD) after pregnancy. Currently, the two main options for treating this pain are general anesthesia (full medically induced unconsciousness) and using intravenous medications to reduce the pain and decrease anxiety. The EAGLET-CS Pilot is a pilot randomized trial that will test the feasibility of comparing the impact of these two options for preventing PTSD in a rigorous way for those patients who experience pain during their cesarean section after the baby is out.

Подробное описание

The EAGLET-CS Pilot is a randomized trial that will assess the feasibility of comparing two commonly used approaches to care for women undergoing cesarean delivery under standard neuraxial anesthesia (epidural, spinal, or CSE) who experience intraoperative pain after delivery that is refractory to first line treatments. 12 patients recruited from the labor and delivery service at the Hospital of the University of Pennsylvania will be assigned to one of two standard-care comparators, namely early conversion to general anesthesia versus a time-limited trial of intravenous sedation, followed by conversion to general anesthesia if needed due to ongoing pain. Patients will be assessed during hospitalization and at up to 6 weeks after delivery to assess mental health, medical, and quality of recovery outcomes.

Вмешательства

Другое General anesthetic
standard of care general anesthesia
Другое Intravenous anesthetic
standard of care intravenous anesthesia

Первичные конечные точки

Consent [Срок оценки: From hospital admission through day of delivery]

Вторичные конечные точки (9)

Percentage of patients meeting all inclusion criteria out of all screened [Срок оценки: From hospital admission through day of delivery]
Randomization [Срок оценки: From hospital admission through day of delivery]
Quality of postoperative recovery [Срок оценки: Postoperative day 0, 1, 2, or 3]
Satifaction with anesthesia [Срок оценки: Postoperative day 0, 1, 2, or 3]
Severity and duration of pain [Срок оценки: Postoperative day 0, 1, 2, or 3]
Adverse events [Срок оценки: Randomization through postoperative day 30]
Length of stay [Срок оценки: Randomization through postoperative day 30]
Need for intensive care [Срок оценки: Randomization through postoperative day 30]
New PTSD (Posttraumatic Stress Disorder) symptoms [Срок оценки: Postoperative 6 week]

Критерии участия

Критерии включения

Women aged 18 or older undergoing non-emergent cesarean delivery with primary neuraxial (epidural, spinal, or CSE) anesthesia. Eligible patients will be those who report severe pain during surgery, defined as pain that does not resolve with 2 trials of first-line pharmacologic therapies (e.g., epidural supplementation with local anesthetics; intravenous opioid analgesics).