Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia
Intravenous Dexamethasone Versus Ondansetron in the Prevention of Post-Spinal Hypotension in Preeclampsia Patients Undergoing Caesarean Delivery: A Prospective Randomized Clinical 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Peripartum bleeding.
- Obesity (body mass index ≥40 kg/m²).
- Coagulation disorders (platelet count < 75,000/μL).
- Neurological disorders.
- Previous or current systemic corticosteroid therapy.
- Known cardiac disease.
- History of diabetes mellitus.
- Renal dysfunction (serum creatinine > 2 mg/dL).
- Hepatic dysfunction (serum liver enzymes > 2 times the upper limit of normal).
- Known hypersensitivity to dexamethasone, ondansetron, or any component of the study medications.
- Emergency cesarean delivery.
- Known fetal congenital anomalies.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of post-spinal hypotension
Tidsramme: 1 hour
|
Number of participants with a decrease in systolic blood pressure below 80% of baseline.
|
1 hour
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Graviditetskomplikationer
- Hypertension, graviditetsinduceret
- Præeklampsi
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Azoler
- Polycykliske forbindelser
- Imidazoler
- Indoler
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Heterocykliske forbindelser, 3-ring
- Carbazoler
- Dexamethason
- Ondansetron
Andre undersøgelses-id-numre
- Dex vs Ondan: Spinal BP in PE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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