What side effects are associated with this type of intervention?

Phenylephrine, a common treatment for intraoperative hypotension, primarily works by vasoconstriction to increase blood pressure. Known side effects include reflex bradycardia, hypertension, headache, and anxiety. Rare but severe side effects can include arrhythmias and ischemia. Its use has also been associated with increased mortality in septic shock patients during norepinephrine shortages, though causality is unclear.

What prior FDA approvals exist?

Phenylephrine is an FDA-approved vasopressor commonly used to treat intraoperative hypotension. It works by causing vasoconstriction, which leads to an increase in blood pressure. Other similar FDA-approved vasopressors include norepinephrine and epinephrine, which also act to increase vascular tone and elevate blood pressure during surgical procedures.

What other types of research exist?

Promising novel alternatives to Phenylephrine for intraoperative hypotension include vasopressin and its analogues, as well as selective phosphodiesterase (PDE) III inhibitors like E-1020 (loprinone hydrochloride) and R 80122. These agents have shown efficacy in managing hypotensive conditions and may offer benefits in the intraoperative setting.

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Phenylephrine for Low Blood Pressure

Q: What is the mechanism of action of this treatment?

The most common treatments for intraoperative hypotension, such as phenylephrine, work by causing vasoconstriction through the stimulation of alpha-1 adrenergic receptors in blood vessels. This leads to an increase in blood pressure, which is essential for maintaining adequate organ perfusion and preventing complications during surgery. By quickly restoring blood pressure, these treatments help ensure that tissues receive sufficient oxygen, thereby reducing the risk of organ dysfunction.

Phase < 1

Waitlist Available

Led By Noah Jouett, DO/PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 45 years of age

Be between 18 and 65 years old

Must not have

Subject on anticoagulant treatment

Any known history of renal or hepatic insufficiency/disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up thirty minutes following phenylephrine infusion

Summary

This trial is testing phenylephrine, a drug that raises blood pressure, in surgery patients with low blood pressure. The study aims to understand how this drug affects fluid management during surgery.

Who is the study for?

This trial is for adults aged 18-45 with low blood pressure who are not obese, do not smoke, and have no serious mental illnesses or history of heart, vascular, respiratory, neurological/metabolic diseases. Pregnant or breastfeeding individuals and those with renal/hepatic issues or sulfite allergies cannot participate.

What is being tested?

The study tests the effects of Phenylephrine (a vasopressor) versus a saline placebo on Pulse Pressure Variability in simulated hypovolemia during surgery. It aims to inform anesthesiologists on using PPV when patients need drugs to raise blood pressure.

What are the potential side effects?

Phenylephrine may cause side effects like headache, increased heart rate, irregular heartbeat, high blood pressure spikes and possibly anxiety. Reactions can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on blood thinner medication.

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I have a history of kidney or liver problems.

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I have a heart, blood vessel, lung, nerve, or metabolic condition.

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I am allergic to sulfites.

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I have peripheral vascular disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ thirty minutes following phenylephrine infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~thirty minutes following phenylephrine infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and thirty minutes following phenylephrine infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pulse Pressure Variability

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PhenylephrineExperimental Treatment1 Intervention

Phenylephrine infusion (0.3 mcg/kg/hr)

Group II: ControlPlacebo Group1 Intervention

Saline infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phenylephrine

2014

Completed Phase 4

~2040

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for intraoperative hypotension, such as phenylephrine, work by causing vasoconstriction through the stimulation of alpha-1 adrenergic receptors in blood vessels. This leads to an increase in blood pressure, which is essential for maintaining adequate organ perfusion and preventing complications during surgery. By quickly restoring blood pressure, these treatments help ensure that tissues receive sufficient oxygen, thereby reducing the risk of organ dysfunction.

Peri-operative hemodynamic therapy: only large clinical trials can resolve our uncertainty.