NCT01481740

Brief Summary

Previous research regarding the use of phenylephrine has excluded obese subjects (BMI \>35). This subgroup of patients represents a large portion of the obstetric patient population locally and nationally. It is unclear whether previous research should be extrapolated to the obese patient population. This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension. This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

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

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 2, 2016

Completed
Last Updated

April 23, 2018

Status Verified

March 1, 2018

Enrollment Period

4.1 years

First QC Date

July 22, 2011

Results QC Date

September 14, 2016

Last Update Submit

March 22, 2018

Conditions

Hypotension

Keywords

spinal induced hypotensionnausea and vomitingcesarean delivery

Outcome Measures

Primary Outcomes (3)

  • Incidence of Nausea and Vomiting

    intraoperative 2-3 hours

  • Incidence of Nausea and Vomiting

    2 hrs postoperative

  • Incidence of Nausea and Vomiting

    24hrs postoperative

Secondary Outcomes (3)

  • Incidence of Hypotension

    intraoperative - predelivery

  • Incidence of Hypotension

    intraoperative - postdelivery

  • Neonatal Acidosis

    intraoperative

Study Arms (2)

Phenylephrine bolus

EXPERIMENTAL
Drug: Phenylephrine bolus

Phenylephrine infusion

EXPERIMENTAL
Drug: phenylephrine infusion

Interventions

Phenylephrine bolusDRUG

10 ml of 100mcg/ml phenylephrine and placebo infusion

Phenylephrine bolus
phenylephrine infusionDRUG

60ml infusion of 100mcg/ml phenylephrine and placebo bolus

Phenylephrine infusion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • ASA Physical Status I-II
  • Non-laboring women
  • Single gestations ≥ 36 weeks
  • Obese women (Body Mass Index 35 - 55 kg/m2)
  • Non-emergent CD under spinal anesthesia

You may not qualify if:

  • Height \< 5'0"
  • Antiemetic drug use in the 24 hours prior to CD
  • Allergy to phenylephrine, or any other standardized medication
  • Hypertensive disease of pregnancy (i.e. mild \& severe preeclampsia)
  • Chronic hypertension receiving antihypertensive treatment
  • Severe Cardiac disease in pregnancy with marked functional limitations
  • Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
  • Subject enrollment in another study involving a study medication within 30 days of CD
  • Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

IWK Health Centre

Halifax, Nova Scotia, B3H 6K8, Canada

Location

Related Publications (1)

  • George RB, McKeen DM, Dominguez JE, Allen TK, Doyle PA, Habib AS. A randomized trial of phenylephrine infusion versus bolus dosing for nausea and vomiting during Cesarean delivery in obese women. Can J Anaesth. 2018 Mar;65(3):254-262. doi: 10.1007/s12630-017-1034-6. Epub 2017 Dec 5.

    PMID: 29209926DERIVED

MeSH Terms

Conditions

HypotensionNauseaVomiting

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Ronald B George
Organization
Department of Women's & Obstetric Anesthesia, IWK Health Centre
rbgeorge@dal.ca
902-470-6627

Study Officials

  • Ronald B George, MD FRCPC

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator, MD, FRCPC, Assistant Professor

Study Record Dates

First Submitted

July 22, 2011

First Posted

November 30, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 23, 2018

Results First Posted

November 2, 2016

Record last verified: 2018-03

Locations

US(1)CA(1)