Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension

November 6, 2017 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: phenylephrine 50mcg bolus
Phenylephrine 50 mcg bolus dosing with continuous placebo infusion
Drug: Phenylephrine
Experimental: Phenylephrine 100 mcg bolus
Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion.
Drug: Phenylephrine
Experimental: Phenylephrine continuous infusion 100mcg/min
Continuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing.
Drug: Phenylephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of cardiac output changes
Time Frame: 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.
0-90 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Peter Pan, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 31, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 26872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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