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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07678723
Enrollment
200
Registered
2026-07-01
Start date
2026-06-28
Completion date
2026-10-31
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery, Hypotension, Spinal Anesthesia

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

OTHERNot 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.

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Incidence of Hypotension After Spinal Anesthesia0-20 minutes after spinal anesthesiaHypotension 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

MeasureTime frameDescription
Incidence of Severe Hypotension0-20 minutes after spinal anesthesiaSevere hypotension defined as systolic blood pressure \<80 mmHg or requiring vasopressor administration.
Total Vasopressor Dose AdministeredIntraoperative period (first 20 minutes post-spinal)Total amount of vasopressor medication administered to treat hypotension following spinal anesthesia.
Maternal Symptoms Associated With HypotensionIntraoperative periodAssessment of maternal symptoms including nausea, vomiting, dizziness, or discomfort associated with hypotension.
Neonatal Apgar Scores1 minute and 5 minutes postpartumApgar scores at 1 and 5 minutes after delivery.
Umbilical Artery pHImmediately after deliveryMeasurement of umbilical artery blood pH to assess neonatal acid-base status.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026