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Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

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ClinicalTrials.gov Identifier: NCT01216410
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : March 25, 2013
Last Update Posted : August 6, 2014
Sponsor:
Collaborator:
IWK Health Centre
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Cesarean Delivery Drug: Metoclopramide Drug: Phenylephrine infusion Drug: Combination Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : December 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011


Arm Intervention/treatment
Active Comparator: Metoclopramide
Prophylaxis with metoclopramide and phenylephrine infusion.
Drug: Metoclopramide
Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion

Placebo Comparator: Phenylephrine infusion
Prophylactic phenylephrine infusion and placebo antiemetics
Drug: Phenylephrine infusion
Prophylactic phenylephrine infusion after spinal and placebo antiemetics

Active Comparator: Combination Group
Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion
Drug: Combination Group
Metoclopramide and ondansetron prophylaxis with phenylephrine infusion
Other Name: Metoclopramide and ondansetron




Primary Outcome Measures :
  1. Intraoperative Nausea and Vomiting [ Time Frame: Intraoperatively ]
    Comparison of intraoperative nausea and vomiting between the 3 groups.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216410


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
IWK Health Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01216410     History of Changes
Other Study ID Numbers: Pro00012142
Duke-12142
First Posted: October 7, 2010    Key Record Dates
Results First Posted: March 25, 2013
Last Update Posted: August 6, 2014
Last Verified: July 2014
Keywords provided by Duke University:
Nausea
Vomiting
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Phenylephrine
Oxymetazoline
Ondansetron
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Cardiotonic Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents