Complications; Cesarean Section, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Conditions
Keywords
cesarean section, hypotension, phenylephrine
Brief summary
Three different regimens of phenylephrine are being evaluated to see if one is superior over the other in the maintenance of cardiac output while keeping normotension and/or treating hypotension experienced when receiving spinal anesthesia for cesarean delivery.
Detailed description
Phenylephrine will be administered in one of 3 regimens: Intermittent bolus of 50 mcg, Intermittent bolus of 100 mcg, or continuous infusion of 100 mcg/min. The infusion will contain either phenylephrine or normal saline (placebo). Subjects who are randomized to receive a bolus dose will receive placebo in the infusion. Subjects who are randomized to receive the phenylephrine infusion will have normal saline (placebo) in the bolus syringe. Baseline blood pressures will be obtained prior to surgery and then maintained using these drugs. Blood pressure and heart rate will be monitored as usual standard of care. Continuous cardiac output and hemodynamic monitoring will be obtained using CNAP (Tm) or similar (equivalent) monitoring device. Blood pressure will be maintained at 90-120% of baseline utilizing infusion and/or bolus with the 3 regimens.
Interventions
DRUGPhenylephrine
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* scheduled for cesarean delivery age \>/=18 years of age \>/= 37 weeks EGA ASA status I-III
Exclusion criteria
* allergy to medications used in the study non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude of cardiac output changes | 0-90 minutes | Magnitude of cardiac output reduction for the duration from preoperative baseline from time of spinal anesthesia to delivery of fetus and placenta. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vasopressor requirement | 0-90 minutes | total amount of vasopressor or equivalent required |
| Emetic symptoms | 0-90 minutes | emetic symptoms - magnitude and/or incidence |
| hypertension | 0-90 minutes | incidence and magnitude |
| provider intervention | 0-90 minutes | number of provider intervention to treat abnormal hemodynamics |
| bradycardia | 0-90 minutes | incidence and magnitude |
| Anesthetic time | up to 120 minutes | — |
| hypotension | 0-90 minutes | incidence and magnitude |
Countries
United States
Outcome results
None listed