Clinical trial NCT01481740: Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)
Official title: A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Keywords: spinal induced hypotension
nausea and vomiting
cesarean delivery
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2011-11-30
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Nausea and Vomiting
timeFrame: intraoperative 2-3 hours
measure: Incidence of Nausea and Vomiting
timeFrame: 2 hrs postoperative
measure: Incidence of Nausea and Vomiting
timeFrame: 24hrs postoperative
Secondary outcomes:
measure: Incidence of Hypotension
timeFrame: intraoperative - predelivery
measure: Incidence of Hypotension
timeFrame: intraoperative - postdelivery
measure: Neonatal Acidosis
timeFrame: intraoperative
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Ronald B George, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.