Cesarean Delivery, Hypotension, Spinal Anesthesia
Conditions
Keywords
Pupillary Light Reflex, Pupillometry, Spinal Anesthesia, Hypotension, Cesarean Section, Obstetric Anesthesia
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
ASA II Term pregnancy ≥37 weeks Singleton pregnancy Elective cesarean section Age 18-45 years Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypotension After Spinal Anesthesia | 0-20 minutes after spinal anesthesia | Hypotension defined as a \>20% decrease in systolic blood pressure from baseline within the first 20 minutes after spinal anesthesia administration. Blood pressure is measured every 5 minutes as per protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severe Hypotension | 0-20 minutes after spinal anesthesia | Severe hypotension defined as systolic blood pressure \<80 mmHg or requiring vasopressor administration. |
| Total Vasopressor Dose Administered | Intraoperative period (first 20 minutes post-spinal) | Total amount of vasopressor medication administered to treat hypotension following spinal anesthesia. |
| Maternal Symptoms Associated With Hypotension | Intraoperative period | Assessment of maternal symptoms including nausea, vomiting, dizziness, or discomfort associated with hypotension. |
| Neonatal Apgar Scores | 1 minute and 5 minutes postpartum | Apgar scores at 1 and 5 minutes after delivery. |
| Umbilical Artery pH | Immediately after delivery | Measurement of umbilical artery blood pH to assess neonatal acid-base status. |