Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Cesarean Delivery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216410
• Other study ID #: Pro00012142
• Secondary ID: Duke-12142
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: August 4, 2014
• Start date: December 2008
• Est. completion date: April 2011

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Delivery
• Vomiting

Intervention

Drug:
• Metoclopramide
Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion
• Phenylephrine infusion
Prophylactic phenylephrine infusion after spinal and placebo antiemetics
• Combination Group
Metoclopramide and ondansetron prophylaxis with phenylephrine infusion

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	IWK Health Centre

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Nausea and Vomiting	Comparison of intraoperative nausea and vomiting between the 3 groups.	Intraoperatively	No
Secondary	Postoperative Nausea and Vomiting (PONV)		0-2h, 2-6h, 6-24h	No
Secondary	Pruritus		0-24 hrs	No
Secondary	Satisfaction	1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.	24 h	No
Secondary	Maternal Hemodynamics	The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively	Intraoperatively	No