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Completed

NCT Number: NCT01216410

Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.

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Key information

Conditions

Cesarean Delivery Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
  • Scheduled or unscheduled cesarean delivery under spinal anesthesia
  • Height: 5 feet-5 feet 11 in.

Exclusion criteria

  • Laboring women needing an emergency cesarean delivery
  • Subjects less than 18 years of age
  • Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section
  • Allergy to ondansetron, or metoclopramide
  • Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
  • Severe Cardiac disease in pregnancy with marked functional limitations
  • Diabetes type I
  • Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
  • Morbid obesity (body mass index (BMI)>45)
  • Inclusion in another anesthetic study involving drug administration

Treatment and study plan

Metoclopramide

Drug

Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion

Phenylephrine infusion

Drug

Prophylactic phenylephrine infusion after spinal and placebo antiemetics

Combination Group

Drug

Metoclopramide and ondansetron prophylaxis with phenylephrine infusion

Other names: Metoclopramide and ondansetron

Primary outcomes

  1. Intraoperative Nausea and Vomiting

    Time frame: Intraoperatively

    Comparison of intraoperative nausea and vomiting between the 3 groups.

Secondary outcomes

  1. Postoperative Nausea and Vomiting (PONV)

    Time frame: 0-2h, 2-6h, 6-24h

  2. Pruritus

    Time frame: 0-24 hrs

  3. Satisfaction

    Time frame: 24 h

    1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.

  4. Maternal Hemodynamics

    Time frame: Intraoperatively

    The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • IWK Health Centre

Registry information

Official study title

The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2010
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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