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Timing Matters: A Randomized Controlled Trial on Extended vs. Brief Pre-Spinal Ondansetron Administration for Maternal Hypotension Prevention in Cesarean Delivery

Timing Matters: A Randomized Controlled Trial on Extended vs. Brief Pre-Spinal Ondansetron Administration for Maternal Hypotension Prevention in Cesarean Delivery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250130001
Enrollment
160
Registered
2025-01-30
Start date
2024-10-01
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

Parturients with uncomplicated singleton term pregnancies Ondansetron, spinal anesthesia, hypotension, cesarean delivery, timing of drug administration

Interventions

consenting parturients who met inclusion criteria were enrolled without receiving any premedication. An 18 gauge venous catheter was inserted in the forearm, and lactated Ringer solution was infused a
Active Comparator Drug,Active Comparator Drug
8 mg of ondansetron (diluted to 10 ml with physiological saline) was delivered to each parturient 30 minutes ,8 mg of ondansetron (diluted to 10 ml with physiological saline) was delivered to each par

Sponsors

None listed

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Parturient of singleton term gestation (37-42 weeks gestation),2. American Society of Anesthesiologists physical status (ASA-PS) class II planned for the elective cesarean section

Exclusion criteria

Exclusion criteria: 1.Parturient having a history of allergy to ondansetron or local anesthetic ,2.Pregnancy induced hypertension (PIH) or preeclampsia ,3.Contraindications to regional anesthesia (patient refusal, unstable hemodynamic, and coagulation abnormalities) ,4.Diabetes, any other coexisting maternal disease ,5.Active or early labor, ruptured membranes, and placenta previa.

Design outcomes

Primary

MeasureTime frame
Incidence of Hypotensive Episodes every 2 minutes after spinal block Non invasive Blood Pressure Monitoring

Secondary

MeasureTime frame
Total Dose of Ephedrine Required 30 minutes after spinal block Medication Administration Record,Maternal Systolic Blood Pressure Levels recorded every 2 minutes after spinal block Non invasive Blood Pressure Monitoring,Maternal Diastolic Blood Pressure Levels recorded every 2 minutes after spinal block Non invasive Blood Pressure Monitoring,mean arterial pressure recorded every 2 minutes after spinal block Non invasive Blood Pressure Monitoring,Heart rate recorded every 2 minutes after spinal block continuously monitored using the electrocardiogram (ECG),Pulse pressure recorded every 2 minutes after spinal block Pulse pressure was calculated as the difference between systolic and diastolic blood pressures measured by noninvasive oscillometric blood pressure monitoring.,Maximum decline in systolic blood pressure recorded every 2 minutes after spinal block determined by comparing the baseline systolic blood pressure (obtained via noninvasive oscillometric blood pressure monitoring) to the lowest systolic blood pressure recorded within 30 minutes.,Apgar score at one minute at one minute after birth determined by qualified personnel using the standard apgar score,Apgar score at five minute at five minute after birth determined by qualified personnel using the standard apgar score

Countries

Thailand

Contacts

Public ContactNathapol Narach

Nan hospital

nathapol041@gmail.com0871755024

Outcome results

None listed

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