Ephedrine Versus Ondansetron During Cesarean Delivery

September 7, 2022 updated by: Raham Hasan Mostafa, MD, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 4

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

  • Egypt
      • Cairo, Egypt
        • Ain shams university hospitals

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 to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group E
Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.
Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution
Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia
Other Names:
  • Ephedrine group
EXPERIMENTAL: Group OL
Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.
Drug: Ondansetron 4 MG
Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia
Other Names:
  • Low dose ondansetron group
EXPERIMENTAL: Group OH
Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.
Drug: Ondansetron 8mg
Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia
Other Names:
  • Higher dose Ondanseteron group
PLACEBO_COMPARATOR: Group P

Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.

Then under aseptic precautions, spinal anesthesia was administered.
Other: 10 mL normal saline
10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia
Other Names:
  • Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apgar score
Time Frame: 5 min after fetal delivery
1and 5 min after fetal delivery
5 min after fetal delivery

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 (ACTUAL)

January 10, 2022

Primary Completion (ACTUAL)

March 1, 2022

Study Completion (ACTUAL)

March 6, 2022

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (ACTUAL)

November 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R 04 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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