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Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension

NCT ID: NCT02101047

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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cesarean section hypotension phenylephrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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phenylephrine 50mcg bolus

Phenylephrine 50 mcg bolus dosing with continuous placebo infusion

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Phenylephrine 100 mcg bolus

Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion.

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Phenylephrine continuous infusion 100mcg/min

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

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Interventions

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Phenylephrine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Pan, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 26872

Identifier Type: -

Identifier Source: org_study_id