Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension

Complications; Cesarean Section Clinical Trial

Official title:

Correlation and Effects on Cardiac Output With Intermittent Phenylephrine Administration of 50 mcg Versus 100 mcg or 100mcg/Min Prophylactic Infusion for Treatment of Hypotension in Parturients After Receiving Spinal Anesthesia for Cesarean Delivery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02101047
• Other study ID #: IRB 26872
• Status: Withdrawn
• Phase: N/A
• First received: March 27, 2014
• Last updated: November 6, 2017
• Start date: August 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Hypotension
• Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Intervention

Drug:
• Phenylephrine

Locations

Country	Name	City	State
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of cardiac output changes	Magnitude of cardiac output reduction for the duration from preoperative baseline from time of spinal anesthesia to delivery of fetus and placenta.	0-90 minutes
Secondary	provider intervention	number of provider intervention to treat abnormal hemodynamics	0-90 minutes
Secondary	vasopressor requirement	total amount of vasopressor or equivalent required	0-90 minutes
Secondary	Emetic symptoms	emetic symptoms - magnitude and/or incidence	0-90 minutes
Secondary	hypertension	incidence and magnitude	0-90 minutes
Secondary	hypotension	incidence and magnitude	0-90 minutes
Secondary	bradycardia	incidence and magnitude	0-90 minutes
Secondary	Anesthetic time		up to 120 minutes