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NCT Number: NCT07678723

Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable- observational study

Other

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.

Primary outcomes

  1. Incidence of Hypotension After Spinal Anesthesia

    Time frame: 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 outcomes

  1. Incidence of Severe Hypotension

    Time frame: 0-20 minutes after spinal anesthesia

    Severe hypotension defined as systolic blood pressure <80 mmHg or requiring vasopressor administration.

  2. Total Vasopressor Dose Administered

    Time frame: Intraoperative period (first 20 minutes post-spinal)

    Total amount of vasopressor medication administered to treat hypotension following spinal anesthesia.

  3. Maternal Symptoms Associated With Hypotension

    Time frame: Intraoperative period

    Assessment of maternal symptoms including nausea, vomiting, dizziness, or discomfort associated with hypotension.

  4. Neonatal Apgar Scores

    Time frame: 1 minute and 5 minutes postpartum

    Apgar scores at 1 and 5 minutes after delivery.

  5. Umbilical Artery pH

    Time frame: Immediately after delivery

    Measurement of umbilical artery blood pH to assess neonatal acid-base status.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Pupillary Light Reflex for Predicting Hypotension Risk After Spinal Anesthesia for Elective Cesarean Section: A Prospective Observational Cohort Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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