Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia

Sponsor
Assiut University
Study ID
NCT07793760
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Cesarean Section
  • Preeclampsia
  • Spinal Anesthesia-Induced Hypotension

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group D: Dexamethasone
    Patients in Group D will receive 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 anaesthesia.
  • Active Comparator: Group O: Ondansetron
    Patients in Group O will receive 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 anaesthesia.

Primary Outcome Measure

Incidence of post-spinal hypotension [ Time Frame: 1 hour ]

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