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

NCT02194192 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2015-03-17

No results posted yet for this study

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.

Conditions

  • Anesthesia; Adverse Effect, Spinal and Epidural

Interventions

DRUG

Placebo

Normal saline 10 ml

DRUG

Ondansetron

Ondasetron 8 mg IV after spinal anesthesia

DRUG

Ephedrine

Ephedrine 10 mg IV after spinal anesthesia

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Patchareya Nivatpumin, M.D. · Department of Anesthesiology, Faculty of Medicine Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Thailand

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02194192 on ClinicalTrials.gov