Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section

Not Applicable

Completed

• Conditions: Anesthesia; Adverse Effect, Spinal and Epidural
• Interventions: Drug: Placebo; Drug: Ondansetron; Drug: Ephedrine

• Registration Number: NCT02194192
• Lead Sponsor: Mahidol University

Brief Summary

Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a very common problem leading to several complications to both patients and their babies. It can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important complication is the decreasing blood flow to babies; which may lead to fetal acidosis.

Many interventions has been studied in order to prevent hypotension after spinal anesthesia in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine, phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic drug) can be effectively used to prevent hypotension after spinal anesthesia in normal patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish reflex.

This aim of this study is to compare the efficacy of ephedrine and ondansetron in the prevention of maternal hypotension after spinal anesthesia in cesarean section.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-18
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

• Age > 18 years
• Elective cesarean section
• Patient accept spinal anesthesia
• ASA classification I-II
• Term, Singleton pregnancy
• Understand all process in this study

Exclusion Criteria

• DM any type that not the gestational DM
• Hypertensive disorder
• BMI>40
• Complicated pregnancy such as placenta previa, preeclampsia
• Allergic to study drugs
• Long QT syndrome
• Contraindication to spinal anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group P	Placebo	Normal saline 10 ml
Group O	Ondansetron	Ondansetron 8 mg in Normal saline 10 ml
Group E	Ephedrine	Ephedrine 10 mg in Normal Saline 10 ml

Primary Outcome Measures

Name	Time	Method
Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.	After spinal block to until baby delivered	Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery.

Secondary Outcome Measures

Name	Time	Method
Maternal symptom: Nausea and vomiting after spinal anesthesia	After spinal anesthesia until baby delivered

Trial Locations

Locations (1)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand