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NCT Number: NCT05127876

Ephedrine Versus Ondansetron During Cesarean Delivery

More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death.

The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals

Cairo, Egypt

About this study

Some vasopressive drugs including ephedrine and phenylephrine have been widely used to prevent maternal hypotension. Although ephedrine has mixed a-adrenoceptor activity , it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors. It has been demonstrated that ondansetron preloading with crystalloid infusion reduces maternal hypotension in parturient women undergoing cesarean delivery.

Ondansetron has been widely used in the clinic to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron has been proven as a well-tolerated drug, but the most common side effects of ondansetron include headache, constipation, diarrhea, asthenia, and somnolence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age >18, <40 years;
  • American Society of Anesthesiologists physical status I or II;
  • term pregnancy
  • singleton pregnancy;
  • elective cesarean delivery under spinal anesthesia

Exclusion criteria

  • Patients with a history of diabetes mellitus other than gestational diabetes,
  • hypertension,
  • body mass index >40 kg/m2,
  • complicated pregnancy, allergy to study drugs,
  • long QT syndrome,
  • Contraindication to spinal anesthesia
  • Patients who required general anesthesia were withdrawn from the study.

Treatment and study plan

Ondansetron 4 MG

Drug

Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia

Other names: Low dose ondansetron group

Ondansetron 8mg

Drug

Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia

Other names: Higher dose Ondanseteron group

EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution

Drug

Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia

Other names: Ephedrine group

10 mL normal saline

Other

10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia

Other names: Placebo group

Primary outcomes

  1. Incidence of Maternal hypotension

    Time frame: 45 minutes

    Mean arterial blood pressure was recorded every 2 minute for 10 minutes then every 5 minutes until delivery. Time of intrathecal injection was considered as 0 min.

Secondary outcomes

  1. Apgar score

    Time frame: 5 min after fetal delivery

    1and 5 min after fetal delivery

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Sep 9, 2022

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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