Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Not applicable- observational study.
- Кому может быть актуально
- Состояния в реестре: Hypotension, Spinal Anesthesia, Cesarean Delivery. Базовые параметры: 18 лет — 45 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Pupillary Light Reflex for Predicting Hypotension Risk After Spinal Anesthesia for Elective Cesarean Section: A Prospective Observational Cohort Study
Обзор
This prospective observational cohort study investigates whether pre-anesthetic pupillary light reflex (PLR) parameters can predict the risk of hypotension following spinal anesthesia in women undergoing elective cesarean section. Spinal anesthesia-induced hypotension is common, with reported incidence rates of 50-90%, and current predictors such as baseline blood pressure and BMI have limited accuracy. PLR, a sensitive marker of autonomic nervous system balance, may offer a simple, objective, and non-invasive tool for identifying patients at higher risk. The study evaluates pupillary reaction latency and other PLR parameters and correlates them with post-spinal blood pressure changes to determine their predictive value.
Подробное описание
Spinal anesthesia is the standard technique for elective cesarean delivery, yet it is frequently associated with maternal hypotension due to sympathetic blockade. According to the study protocol, spinal anesthesia-induced hypotension (SAIH) occurs in 50-90% of cases, and currently available predictors-including baseline blood pressure, BMI, and block height-demonstrate limited accuracy (AUC \<0.65). The pupillary light reflex (PLR) is a sensitive indicator of autonomic nervous system balance, and pupillary reaction latency may reflect parasympathetic conduction efficiency. As noted in the protocol, no published studies have evaluated PLR as a predictor of hypotension after spinal anesthesia in obstetric patients.
This prospective observational cohort study aims to determine whether pre-anesthetic PLR parameters, particularly pupillary reaction latency, can predict the occurrence and severity of hypotension following spinal anesthesia for elective cesarean section. Additional pupillometry parameters-including baseline diameter, constriction velocity, and minimum diameter-will also be assessed. Measurements are obtained using a handheld pupillometer after 5 minutes of dark adaptation, with three readings taken at 60-second intervals.
Following spinal anesthesia with hyperbaric bupivacaine and fentanyl, maternal blood pressure is monitored every 5 minutes for the first 20 minutes. The primary outcome is hypotension, defined as a \>20% decrease in systolic blood pressure. Secondary outcomes include severe hypotension, vasopressor requirements, maternal symptoms, and neonatal Apgar scores and umbilical artery pH.
Statistical analysis includes ROC curve evaluation, Youden's index for cutoff determination, and multivariate logistic regression. The study involves no interventions beyond routine care, and pupillometry is non-invasive and safe. Findings may support the development of a novel, objective, and clinically useful predictor for SAIH in obstetric anesthesia.
Вмешательства
- Другое Not applicable- observational study
This study does not involve any investigational drugs, devices, or therapeutic interventions. Pupillometry is a non-invasive measurement performed as part of the observational assessment and is not considered an intervention.
Первичные конечные точки
- Incidence of Hypotension After Spinal Anesthesia [Срок оценки: 0-20 minutes after spinal anesthesia]
Вторичные конечные точки (5)
- Incidence of Severe Hypotension [Срок оценки: 0-20 minutes after spinal anesthesia]
- Total Vasopressor Dose Administered [Срок оценки: Intraoperative period (first 20 minutes post-spinal)]
- Maternal Symptoms Associated With Hypotension [Срок оценки: Intraoperative period]
- Neonatal Apgar Scores [Срок оценки: 1 minute and 5 minutes postpartum]
- Umbilical Artery pH [Срок оценки: Immediately after delivery]
Критерии участия
Критерии включения
ASA II Term pregnancy ≥37 weeks Singleton pregnancy Elective cesarean section Age 18-45 years Written informed consent
Критерии исключения
Emergency cesarean section Hypertensive disorders Diabetes mellitus Cardiovascular disease Neurological or autonomic disorders Ophthalmic disease Medications affecting autonomic function BMI >40 kg/m² Failed spinal anesthesia
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07678723 · DFM-IRB 00012367- 26-06-005