Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)

Study Overview
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Brief Summary
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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.

Official Title
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A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients

Conditions
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Hypotension

Intervention / Treatment
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* Drug: Phenylephrine bolus
* Drug: phenylephrine infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenylephrine bolus<br> | Drug: Phenylephrine bolus<br>* 10 ml of 100mcg/ml phenylephrine and placebo infusion<br>|
| Experimental: Phenylephrine infusion<br> | Drug: phenylephrine infusion<br>* 60ml infusion of 100mcg/ml phenylephrine and placebo bolus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hypotension |  | intraoperative - predelivery | 
| Incidence of Hypotension |  | intraoperative - postdelivery | 
| Neonatal Acidosis |  | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal induced hypotension, nausea and vomiting, cesarean delivery