Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia

ConditionsPreeclampsia Spinal Anesthesia-Induced Hypotension Cesarean Section

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18-40

SponsorAssiut University

About this trial

This study compares the efficacy and safety of intravenous dexamethasone versus intravenous ondansetron in preventing low blood pressure (hypotension) following spinal anesthesia in pregnant women with preeclampsia undergoing scheduled cesarean delivery.

Spinal anesthesia is the preferred anesthetic method for cesarean delivery, but it frequently causes a sudden drop in maternal blood pressure. In patients with preeclampsia, post-spinal hypotension can compromise blood flow to the placenta and vital organs. While traditional vasopressor medications are used to restore blood pressure, non-adrenergic prophylactic agents such as dexamethasone and ondansetron may help maintain hemodynamic stability through different physiological pathways.

Participants will be randomly assigned to receive either intravenous dexamethasone (8 mg) or intravenous ondansetron (4 mg) 15 minutes prior to the initiation of spinal anesthesia. Blood pressure, heart rate, vasopressor requirements, optic nerve sheath diameter, and maternal and neonatal outcomes will be monitored throughout the surgery and during the immediate postoperative period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women aged 18 to 40 years.

American Society of Anesthesiologists (ASA) physical status III.

Diagnosed with preeclampsia (new onset of hypertension ≥140/90 mmHg with proteinuria occurring after 20 weeks of gestation according to ACOG and ISSHP guidelines).

Scheduled for elective cesarean delivery under spinal anesthesia.

Disqualifiers

Peripartum bleeding.

Obesity (body mass index ≥40 kg/m²).

Coagulation disorders (platelet count < 75,000/μL).

Neurological disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

Dexamethasone
Drug
Intravenous dexamethasone 8 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anesthesia.
Ondansetron
Drug
Intravenous ondansetron 4 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anesthesia.

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: Group D: DexamethasoneExperimental treatment 1 intervention

Group B: Group O: OndansetronActive comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of post-spinal hypotension

Number of participants with a decrease in systolic blood pressure below 80% of baseline.

Time frame

1 hour

Locations

This trial has no locations.

Sponsors and contacts

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

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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