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

March 13, 2015 updated by: Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group E
Ephedrine 10 mg in Normal Saline 10 ml
Drug: Ephedrine
Ephedrine 10 mg IV after spinal anesthesia
ACTIVE_COMPARATOR: Group O
Ondansetron 8 mg in Normal saline 10 ml
Drug: Ondansetron
Ondasetron 8 mg IV after spinal anesthesia
PLACEBO_COMPARATOR: Group P
Normal saline 10 ml
Drug: Placebo
Normal saline 10 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After spinal block to until baby delivered

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal symptom: Nausea and vomiting after spinal anesthesia
Time Frame: After spinal anesthesia until baby delivered
After spinal anesthesia until baby delivered

Other Outcome Measures

Outcome Measure
Time Frame
Apgar score
Time Frame: one minute and five minute after delivery
one minute and five minute after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (ESTIMATE)

July 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 810/2556(EC2)
  • (IO)R015731034 (OTHER_GRANT: Faculty of medicine Siriraj Hospital, Mahidol University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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