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Completed

NCT Number: NCT02194192

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

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.

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Key information

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Normal saline 10 ml

ondansetron

Drug

Ondasetron 8 mg IV after spinal anesthesia

Ephedrine

Drug

Ephedrine 10 mg IV after spinal anesthesia

Primary outcomes

  1. Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.

    Time frame: 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 outcomes

  1. Maternal symptom: Nausea and vomiting after spinal anesthesia

    Time frame: After spinal anesthesia until baby delivered

Other outcomes

  1. Apgar score

    Time frame: one minute and five minute after delivery

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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