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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after major non-cardiac surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of major perfusion-related complications
Secondary outcome measures
Postoperative delirium

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.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,359,822 Total Patients Enrolled
Daniel I Sessler, MDStudy ChairThe Cleveland Clinic
33 Previous Clinical Trials
91,034 Total Patients Enrolled

Media Library

Tight Pressure Management with phenylephrine Clinical Trial Eligibility Overview. Trial Name: NCT04934748 — Phase 4
High Blood Pressure Research Study Groups: Tight Pressure Management with phenylephrine, Tight Pressure Management with norepinephrine, Routine Pressure Management with phenylephrine, Routine Pressure Management with norepinephrine
High Blood Pressure Clinical Trial 2023: Tight Pressure Management with phenylephrine Highlights & Side Effects. Trial Name: NCT04934748 — Phase 4
Tight Pressure Management with phenylephrine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04934748 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enrolled to participate in this trial?

"This clinical trial has since concluded its search for participants. Initially posted on July 15th 2021, its records were last updated on September 7th 2022. If you are looking to enroll in other studies, there are currently 104 trials examining hypertension and 38 studies assessing Routine Pressure Management with norepinephrine that are still recruiting patients."

Answered by AI

To what conditions does Routine Pressure Management with norepinephrine provide a therapeutic solution?

"Routine Pressure Management with norepinephrine is ordinarily used to treat pupil, yet has also been proven efficacious in dealing with catarrh, rhinorrhoea, and laryngotracheitis."

Answered by AI

Has the FDA sanctioned Routine Pressure Management with norepinephrine?

"Leveraging the available clinical data, Routine Pressure Management with norepinephrine was rated a 3 out of a possible score of 1 to 3 due its Phase 4 status which denotes FDA approval."

Answered by AI

Are recruitment efforts still underway for this research program?

"As per the details posted on clinicaltrials.gov, this trial is not actively seeking participants at present. It was first posted to the platform on July 15th 2021 and last updated on September 7th 2022; however, 142 other studies are currently enrolling patients."

Answered by AI

Are there analogous studies to Routine Pressure Management with norepinephrine that have been previously executed?

"Currently, 38 different medical studies are being conducted to research the use of norepinephrine in Routine Pressure Management. 8 have entered their third phase and most are based out of Salt Lake City, Utah; however there are 65 other locations where trials for this treatment can be found."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
GUARDIAN (NCT04884802) Sub-study, Phenylephrine v. Norepinephrine
2021. "GUARDIAN (NCT04884802) Sub-study, Phenylephrine v. Norepinephrine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04934748.
~1094 spots leftby Dec 2024
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