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Phenylephrine vs Norepinephrine for Blood Pressure Management During Surgery

Phase 4

Waitlist Available

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

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

Must have

Scheduled for major noncardiac surgery expected to last at least 2 hours

Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life)

Must not have

Are scheduled for intracranial surgery

Are scheduled for carotid artery surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after major non-cardiac surgery

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing whether norepinephrine or phenylephrine is more effective in maintaining a patient's blood pressure during surgery.

Who is the study for?

This trial is for adults over 45 facing major noncardiac surgery lasting at least 2 hours, with certain health risks like heart disease or diabetes. They must be on blood pressure medication and able to have their blood pressure closely monitored during surgery.

What is being tested?

The study tests whether Phenylephrine or Norepinephrine is better at maintaining target blood pressure during major surgeries in patients who are already part of the GUARDIAN trial.

What are the potential side effects?

Phenylephrine may cause headache, reflex bradycardia (slow heart rate), and possibly raise blood pressure too high. Norepinephrine can also increase blood pressure significantly, potentially causing irregular heartbeat or chest pain.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for a major surgery that is not heart-related and will last at least 2 hours.

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I have a serious health condition that affects my daily life.

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I will be having surgery with general or spinal anesthesia.

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I am at least 45 years old.

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I am on long-term medication for high blood pressure.

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I will have my blood pressure monitored directly during surgery.

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I expect to stay in the hospital overnight or longer.

Exclusion Criteria

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

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I am scheduled for brain surgery.

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I am scheduled for surgery on my carotid artery.

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I need medicine through an IV to help control my blood pressure before surgery.

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I need to be seated in a beach-chair position for my procedure.

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I am scheduled for surgery to remove a pheochromocytoma.

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I am scheduled for a surgery to remove part or all of my kidney.

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I am scheduled for a liver or kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after major non-cardiac surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after major non-cardiac surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after major non-cardiac surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite of major perfusion-related complications

Secondary study objectives

Postoperative delirium

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Tight Pressure Management with phenylephrineActive Control1 Intervention

Pressure maintenance with phenylephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.

Group II: Tight Pressure Management with norepinephrineActive Control1 Intervention

Pressure maintenance with norepinephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.

Group III: Routine Pressure Management with phenylephrineActive Control1 Intervention

Pressure maintenance with phenylephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial

Group IV: Routine Pressure Management with norepinephrineActive Control1 Intervention

Pressure maintenance with norepinephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.

0 / 14Eligibility criteria met