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Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications; Cesarean Section focused on measuring cesarean section, hypotension, phenylephrine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novant Health Forsyth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

phenylephrine 50mcg bolus

Phenylephrine 100 mcg bolus

Phenylephrine continuous infusion 100mcg/min

Arm Description

Phenylephrine 50 mcg bolus dosing with continuous placebo infusion

Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion.

Continuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

provider intervention
number of provider intervention to treat abnormal hemodynamics
vasopressor requirement
total amount of vasopressor or equivalent required
Emetic symptoms
emetic symptoms - magnitude and/or incidence
hypertension
incidence and magnitude
hypotension
incidence and magnitude
bradycardia
incidence and magnitude
Anesthetic time

Full Information

First Posted
March 27, 2014
Last Updated
November 6, 2017
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02101047
Brief Title
Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
lack of eligible participant
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Cesarean Section, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Keywords
cesarean section, hypotension, phenylephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
phenylephrine 50mcg bolus
Arm Type
Experimental
Arm Description
Phenylephrine 50 mcg bolus dosing with continuous placebo infusion
Arm Title
Phenylephrine 100 mcg bolus
Arm Type
Experimental
Arm Description
Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion.
Arm Title
Phenylephrine continuous infusion 100mcg/min
Arm Type
Experimental
Arm Description
Continuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing.
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Primary Outcome Measure Information:
Title
Magnitude of cardiac output changes
Description
Magnitude of cardiac output reduction for the duration from preoperative baseline from time of spinal anesthesia to delivery of fetus and placenta.
Time Frame
0-90 minutes
Secondary Outcome Measure Information:
Title
provider intervention
Description
number of provider intervention to treat abnormal hemodynamics
Time Frame
0-90 minutes
Title
vasopressor requirement
Description
total amount of vasopressor or equivalent required
Time Frame
0-90 minutes
Title
Emetic symptoms
Description
emetic symptoms - magnitude and/or incidence
Time Frame
0-90 minutes
Title
hypertension
Description
incidence and magnitude
Time Frame
0-90 minutes
Title
hypotension
Description
incidence and magnitude
Time Frame
0-90 minutes
Title
bradycardia
Description
incidence and magnitude
Time Frame
0-90 minutes
Title
Anesthetic time
Time Frame
up to 120 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Pan, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novant Health Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States

12. IPD Sharing Statement

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Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension

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