HypotensionNCT07678723
Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
An observational study of Hypotension and Spinal Anesthesia, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Spinal Anesthesia, Cesarean Delivery
- What is being tested?
- Not applicable- observational study
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2026to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- ASA II Term pregnancy ≥37 weeks Singleton pregnancy Elective cesarean section Age 18-45 years Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University Hospitals
Damietta
Osama Mofreh, Assistant Professor, +201023467024, ts.sarhan@outlook.com
Tarik Saber Sarhan
About this study
Official title: Pupillary Light Reflex for Predicting Hypotension Risk After Spinal Anesthesia for Elective Cesarean Section: A Prospective Observational Cohort Study
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.
Read the 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.
- Conditions
- Hypotension, Spinal Anesthesia, Cesarean Delivery
- Being tested
- Not applicable- observational study
- Keywords
- Pupillary Light Reflex, Pupillometry, Spinal Anesthesia, Hypotension, Cesarean Section, Obstetric Anesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-20 minutes after spinal anesthesia
Secondary outcomes (5)
Incidence of Severe Hypotension
Severe hypotension defined as systolic blood pressure <80 mmHg or requiring vasopressor administration.
Measured: 0-20 minutes after spinal anesthesia
Total Vasopressor Dose Administered
Total amount of vasopressor medication administered to treat hypotension following spinal anesthesia.
Measured: Intraoperative period (first 20 minutes post-spinal)
Maternal Symptoms Associated With Hypotension
Assessment of maternal symptoms including nausea, vomiting, dizziness, or discomfort associated with hypotension.
Measured: Intraoperative period
Neonatal Apgar Scores
Apgar scores at 1 and 5 minutes after delivery.
Measured: 1 minute and 5 minutes postpartum
Umbilical Artery pH
Measurement of umbilical artery blood pH to assess neonatal acid-base status.
Measured: Immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start28 Jun 2026
- Primary completion30 Sep 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Saber Sarhan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678723
- Sponsor's protocol ID
- DFM-IRB 00012367- 26-06-005
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillary Light Reflex for Predicting Hypotension Risk After Spinal Anesthesia for Elective Cesarean Section: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07678723
- Acronym / sponsor ID
- DFM-IRB 00012367- 26-06-005
- Conditions
- Hypotension, Spinal Anesthesia, Cesarean Delivery
- Keywords
- Pupillary Light Reflex, Pupillometry, Spinal Anesthesia, Hypotension, Cesarean Section, Obstetric Anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 28 Jun 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Cesarean Section Cohort | – | Other: Not applicable- observational studyPregnant 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- ASA II Term pregnancy ≥37 weeks Singleton pregnancy Elective cesarean section Age 18-45 years Written informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyThis 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. | Other | Elective Cesarean Section Cohort |
Primary outcome
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.
5 secondary outcomes
Incidence of Severe Hypotension
Time frame: 0-20 minutes after spinal anesthesia
Total Vasopressor Dose Administered
Time frame: Intraoperative period (first 20 minutes post-spinal)
Maternal Symptoms Associated With Hypotension
Time frame: Intraoperative period
Neonatal Apgar Scores
Time frame: 1 minute and 5 minutes postpartum
Umbilical Artery pH
Time frame: Immediately after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Spinal Anesthesia, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hypotension After Spinal Anesthesia (time frame: 0-20 minutes after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.