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

NCT07678723 | Not Yet Recruiting

• 1 other identifier: DFM-IRB 00012367- 26-06-005
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypotension; Spinal Anesthesia; Cesarean Delivery

Keywords

Pupillary Light Reflex; Pupillometry; Spinal Anesthesia; Hypotension; Cesarean Section; Obstetric Anesthesia

Outcome Measures

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.

  0-20 minutes after spinal anesthesia

Secondary Outcomes (5)

• Incidence of Severe Hypotension

  0-20 minutes after spinal anesthesia

• Total Vasopressor Dose Administered

  Intraoperative period (first 20 minutes post-spinal)

• Maternal Symptoms Associated With Hypotension

  Intraoperative period

• Neonatal Apgar Scores

  1 minute and 5 minutes postpartum

• Umbilical Artery pH

  Immediately after delivery

Study Arms (1)

Elective Cesarean Section Cohort

Pregnant women (ASA II, term ≥37 weeks) undergoing elective cesarean section under spinal anesthesia. Participants undergo pre-anesthetic pupillometry and routine perioperative monitoring. No interventions are administered beyond standard clinical care.

Other: Not applicable- observational study

Interventions

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.

Elective Cesarean Section Cohort

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• ASA II Term pregnancy ≥37 weeks Singleton pregnancy Elective cesarean section Age 18-45 years Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Intensive Care and Pain Management

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: June 28, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06