NCT01216410

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 25, 2013

Completed
Last Updated

August 6, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

October 6, 2010

Results QC Date

November 19, 2012

Last Update Submit

August 4, 2014

Conditions

Cesarean Delivery

Keywords

NauseaVomiting

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Nausea and Vomiting

    Comparison of intraoperative nausea and vomiting between the 3 groups.

    Intraoperatively

Secondary Outcomes (4)

  • Postoperative Nausea and Vomiting (PONV)

    0-2h, 2-6h, 6-24h

  • Pruritus

    0-24 hrs

  • Satisfaction

    24 h

  • Maternal Hemodynamics

    Intraoperatively

Study Arms (3)

Metoclopramide

ACTIVE COMPARATOR

Prophylaxis with metoclopramide and phenylephrine infusion.

Drug: Metoclopramide

Phenylephrine infusion

PLACEBO COMPARATOR

Prophylactic phenylephrine infusion and placebo antiemetics

Drug: Phenylephrine infusion

Combination Group

ACTIVE COMPARATOR

Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion

Drug: Combination Group

Interventions

MetoclopramideDRUG

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

Metoclopramide
Phenylephrine infusionDRUG

Prophylactic phenylephrine infusion after spinal and placebo antiemetics

Phenylephrine infusion
Combination GroupDRUG

Metoclopramide and ondansetron prophylaxis with phenylephrine infusion

Also known as: Metoclopramide and ondansetron
Combination Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee.

    PMID: 23635626DERIVED

MeSH Terms

Conditions

NauseaVomiting

Interventions

MetoclopramideOndansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Results Point of Contact

Title
Ashraf Habib
Organization
Duke University Medical Center
habib001@dm.duke.edu
919 668 6266

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 7, 2010

Study Start

December 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

August 6, 2014

Results First Posted

March 25, 2013

Record last verified: 2014-07

Locations

US(1)