Hypotension
Conditions
Keywords
spinal induced hypotension, nausea and vomiting, cesarean delivery
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.
Interventions
10 ml of 100mcg/ml phenylephrine and placebo infusion
60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Sponsors
Duke University
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Nausea and Vomiting | intraoperative 2-3 hours |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Hypotension | intraoperative - predelivery |
| Neonatal Acidosis | intraoperative |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phenylephrine Bolus Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion | 79 |
| Phenylephrine Infusion phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus | 81 |
| Total | 160 |
Baseline characteristics
| Characteristic | Phenylephrine Infusion | Total | Phenylephrine Bolus |
|---|---|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 5 | 31 years STANDARD_DEVIATION 5 | 32 years STANDARD_DEVIATION 6 |
| Region of Enrollment Canada | 56 participants | 110 participants | 54 participants |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 81 Participants | 160 Participants | 79 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 79 | 0 / 81 |
| serious Total, serious adverse events | 0 / 79 | 0 / 81 |
Outcome results
Primary
Incidence of Nausea and Vomiting
Time frame: intraoperative 2-3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenylephrine Bolus | Incidence of Nausea and Vomiting | 59 participants |
| Phenylephrine Infusion | Incidence of Nausea and Vomiting | 37 participants |
Primary
Incidence of Nausea and Vomiting
Time frame: 2 hrs postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenylephrine Bolus | Incidence of Nausea and Vomiting | 29 participants |
| Phenylephrine Infusion | Incidence of Nausea and Vomiting | 26 participants |
Primary
Incidence of Nausea and Vomiting
Time frame: 24hrs postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenylephrine Bolus | Incidence of Nausea and Vomiting | 26 participants |
| Phenylephrine Infusion | Incidence of Nausea and Vomiting | 28 participants |
Secondary
Incidence of Hypotension
Time frame: intraoperative - predelivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenylephrine Bolus | Incidence of Hypotension | 59 participants |
| Phenylephrine Infusion | Incidence of Hypotension | 22 participants |
Secondary
Incidence of Hypotension
Time frame: intraoperative - postdelivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenylephrine Bolus | Incidence of Hypotension | 34 participants |
| Phenylephrine Infusion | Incidence of Hypotension | 6 participants |
Secondary
Neonatal Acidosis
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenylephrine Bolus | Neonatal Acidosis | 7.27 pH value | Standard Deviation 0.06 |
| Phenylephrine Infusion | Neonatal Acidosis | 7.27 pH value | Standard Deviation 0.07 |