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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Anesthesia; Adverse Effect, Spinal and Epidural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group E

Ephedrine 10 mg in Normal Saline 10 ml

Group Type EXPERIMENTAL

Ephedrine

Intervention Type DRUG

Ephedrine 10 mg IV after spinal anesthesia

Group O

Ondansetron 8 mg in Normal saline 10 ml

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

Ondasetron 8 mg IV after spinal anesthesia

Group P

Normal saline 10 ml

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline 10 ml

Interventions

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Placebo

Normal saline 10 ml

Intervention Type DRUG

Ondansetron

Ondasetron 8 mg IV after spinal anesthesia

Intervention Type DRUG

Ephedrine

Ephedrine 10 mg IV after spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes