Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Duke University

Status: Completed

Conditions: Cesarean Delivery

Treatments: Drug: Metoclopramide; Drug: Combination Group; Drug: Phenylephrine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01216410

Pro00012142

Duke-12142

Details and patient eligibility

About

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

Enrollment: 306 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 3 patient groups, including a placebo group

Metoclopramide

Active Comparator group

Description:

Prophylaxis with metoclopramide and phenylephrine infusion.

Treatment:

Drug: Metoclopramide

Phenylephrine infusion

Placebo Comparator group

Description:

Prophylactic phenylephrine infusion and placebo antiemetics

Treatment:

Drug: Phenylephrine infusion

Combination Group

Active Comparator group

Description:

Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion

Treatment:

Drug: Combination Group