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Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia

NCT03421860 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-29

No results posted yet for this study

Summary

The purpose of the study is to evaluate the cardiac output changes after an intravenous bolus of ephedrine, phenylephrine, ondansetron or norepinephrine during a spinal anesthetic for a cesarean delivery.

For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study includes 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of four groups.

Conditions

  • Cardiac Output, Low

Interventions

DRUG

cardiac output changes with "ephedrine"

measure cardiac output after giving a bolus of ephedrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

DRUG

cardiac output changes with "phenylephrine"

measure cardiac output after giving a bolus of phenylephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

DRUG

cardiac output changes with "ondansetron"

measure cardiac output after giving a bolus of ondansetron intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

DRUG

cardiac output changes with "nor-epinephrine"

measure cardiac output after giving a bolus of nor-epinephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Sponsors & Collaborators

  • University Tunis El Manar

    lead OTHER

Principal Investigators

  • hayen maghrebi, professor · tunis maternity center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2018-02-23
Completion
2018-03-30

Countries

  • Tunisia

Study Locations

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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 NCT03421860 on ClinicalTrials.gov