Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension

Not Applicable

Withdrawn

• Conditions: Complications; Cesarean Section; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
• Interventions: Drug: Phenylephrine

• Registration Number: NCT02101047
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-01
• Study Start: 2015-08
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine 100 mcg bolus	Phenylephrine	Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion.
phenylephrine 50mcg bolus	Phenylephrine	Phenylephrine 50 mcg bolus dosing with continuous placebo infusion
Phenylephrine continuous infusion 100mcg/min	Phenylephrine	Continuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
bradycardia	0-90 minutes	incidence and magnitude
hypertension	0-90 minutes	incidence and magnitude
Anesthetic time	up to 120 minutes
Emetic symptoms	0-90 minutes	emetic symptoms - magnitude and/or incidence
hypotension	0-90 minutes	incidence and magnitude
vasopressor requirement	0-90 minutes	total amount of vasopressor or equivalent required
provider intervention	0-90 minutes	number of provider intervention to treat abnormal hemodynamics

Trial Locations

Locations (1)

Novant Health Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States