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Prophylactic Ondansetron 4, 6 and 8 Milligrams plus Phenylephrine on Spinal Hypotension after Spinal Anesthesia in Obese Patients undergoing Cesarean Section : A Randomized, Double-Blind Study

Comparison of Prophylactic Ondansetron 4, 6 and 8 Milligrams plus Phenylephrine Intravenous Slow Injection on Spinal hypotension, Vasopressor Consumption and Other Side effects after Spinal Anesthesia in Obese Patients undergoing Cesarean Section : A Randomized, Double-Blind Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250427011
Enrollment
354
Registered
2025-04-27
Start date
2025-05-05
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal hypotension (low blood pressure in pregnant women) occurring during spinal anesthesia for cesarean section in obese pregnant women. Ondansetron, Maternal hypotension, Spinal hypotension, Maternal obesity, Cesarean Section

Interventions

Ondansetron 4mg intravenous injection 10 minutes before spinal anesthesia,Ondansetron 6mg intravenous injection 10 minutes before spinal anesthesia,Ondansetron 8mg intravenous injection 10 minutes bef
Experimental Drug,Experimental Drug,Experimental Drug
Ondansetron 4mg ,Ondansetron 6mg ,Ondansetron 8mg

Sponsors

Chaophrayayommarat Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pregnant women with obesity undergoing cesarean section, 2. ASA (American Society of Anesthesiologists) physical status classification II or III. 3. Age more than 18 years, 4.Term pregnancy (gestational age more than 37 weeks)

Exclusion criteria

Exclusion criteria: 1.Received ondansetron less than 10 minutes before spinal anesthesia, 2.History of cerebrovascular disease, 3.Obstetric complications, such as: Placental abruption, Placenta previa, Fetal abnormalities detected during pregnancy, 4.History of using: Monoamine oxidase inhibitors (MAOIs), Drugs that slow cardiac conduction, 5.Received other intravenous anesthetic drugs (excluding ondansetron, spinal anesthetics, and intrathecal morphine) before delivery of the baby.

Design outcomes

Primary

MeasureTime frame
Spinal hypotension From spinal anesthesia to baby delivery Blood pressure measurement in units of millimeters of mercury (mmHg)

Secondary

MeasureTime frame
Vasopressor Consumption From spinal anesthesia to baby delivery Dose of phenylephrine(microgram) or atropine(milligram) intravenous injection as indicated

Countries

Thailand

Contacts

Public ContactOrnphimon Tanaphuwanont

Chaoprayayommarat hospital

ornphimon.t@gmail.com0645356641

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026