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

Mahidol University

Status: Completed

Conditions: Anesthesia; Adverse Effect, Spinal and Epidural

Treatments: Drug: Ephedrine; Drug: Placebo; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02194192

(IO)R015731034 (Other Grant/Funding Number)

810/2556(EC2)

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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168 participants in 3 patient groups, including a placebo group

Group E

Experimental group

Description:

Ephedrine 10 mg in Normal Saline 10 ml

Treatment:

Drug: Ephedrine

Group O

Active Comparator group

Description:

Ondansetron 8 mg in Normal saline 10 ml

Treatment:

Drug: Ondansetron

Group P

Placebo Comparator group

Description:

Normal saline 10 ml

Treatment:

Drug: Placebo