Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Duke University306 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

306

Conditions

Cesarean Delivery

Interventions

MetoclopramideDRUG

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

Phenylephrine infusionDRUG

Prophylactic phenylephrine infusion after spinal and placebo antiemetics

Combination GroupDRUG

Metoclopramide and ondansetron prophylaxis with phenylephrine infusion

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Intraoperative Nausea and Vomiting

Comparison of intraoperative nausea and vomiting between the 3 groups.

Time frame: Intraoperatively

Secondary Outcomes

Postoperative Nausea and Vomiting (PONV)

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

Pruritus

Time frame: 0-24 hrs

Satisfaction

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

Time frame: 24 h

Maternal Hemodynamics

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

Time frame: Intraoperatively

Data from ClinicalTrials.gov

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