Health TrialsbyHealthPanel

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

ConditionsHypotensionSpinal AnesthesiaCesarean Delivery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Pregnant women (ASA II), aged 18-45 years, with term singleton pregnancies undergoing elective cesarean section under spinal anesthesia at Al-Azhar University Hospital, Damietta. Participants are evaluated using pre-anesthetic pupillometry and routine perioperative monitoring.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Not applicable- observational study

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Elective Cesarean Section Cohort1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Hypotension 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.

Time frame
0-20 minutes after spinal anesthesia

Secondary outcomes

1

Incidence of Severe Hypotension

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

Time frame
0-20 minutes after spinal anesthesia
2

Total Vasopressor Dose Administered

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

Time frame
Intraoperative period (first 20 minutes post-spinal)
3

Maternal Symptoms Associated With Hypotension

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

Time frame
Intraoperative period
4

Neonatal Apgar Scores

Apgar scores at 1 and 5 minutes after delivery.

Time frame
1 minute and 5 minutes postpartum

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: