Blood Pressure Management During Surgery for High Blood Pressure

Recruiting at 17 trial locations

Overseen By Daniel Sessler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must be taking: Antihypertensives

Disqualifiers: Carotid, Intracranial, Nephrectomy, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: During surgery

6254 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if tightly managing blood pressure during major surgeries can reduce serious complications such as heart problems, stroke, infections, or death within 30 days post-operation. Participants will receive either tight blood pressure management with specific medications (vasopressors) or usual care to assess which approach is more effective. Ideal candidates are over 45 years old, scheduled for major surgeries, and have conditions like diabetes requiring medication or a history of heart disease.

As an unphased trial, this study provides participants the chance to contribute to important research that could enhance surgical outcomes for many patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are already taking at least one medication for high blood pressure. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that carefully controlling blood pressure during surgery is safe. Studies have found that this approach stabilizes blood pressure and reduces the risk of it dropping too low during the operation, making significant drops less likely.

Regarding medications used to maintain blood pressure, norepinephrine and phenylephrine are generally well-tolerated, according to research. These drugs help keep blood pressure steady during surgery. Studies have found that they do not cause serious kidney problems and are safe for use during operations.

Overall, both careful blood pressure management and the use of these medications have demonstrated promising safety results in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different strategies for managing blood pressure during surgery in patients with hypertension. The "tight blood pressure management" approach is unique as it specifically avoids the use of certain medications like ACE inhibitors and ARBs on the morning of surgery, and instead relies on norepinephrine or phenylephrine to maintain a higher intraoperative blood pressure. This contrasts with the "routine blood pressure management" that allows the use of standard medications as needed. By testing these approaches, researchers hope to find out if tightly controlling blood pressure with specific infusions offers better outcomes for surgical patients compared to usual care.

What evidence suggests that this trial's treatments could be effective for managing blood pressure during surgery?

Research has shown that carefully controlling blood pressure during surgery helps maintain a healthy level, reducing the risk of low blood pressure linked to heart or kidney issues. This trial will compare two approaches: tight blood pressure management and routine blood pressure management. In the tight blood pressure management arm, medications such as norepinephrine and phenylephrine maintain stable blood pressure during surgery. Studies have found that this careful approach may lower the chances of serious complications after surgery. In short, closely managing blood pressure during surgery could lead to fewer complications and a smoother recovery. ^{1 6 7 8 9}

Who Is on the Research Team?

Daniel I Sessler, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

The GUARDIAN Trial is for adults over 45 with high blood pressure who are taking medication for it and scheduled for major noncardiac surgery lasting at least 2 hours. They must be hospitalized overnight, have a certain level of systemic disease, direct blood pressure monitoring during surgery, and one additional risk factor like heart disease or diabetes. Exclusions include those needing organ transplants or specific surgeries, contraindications to the study drugs, or cognitive impairments.

Inclusion Criteria

I expect to stay in the hospital overnight or longer.

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

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

Exclusion Criteria

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

I am scheduled for brain surgery.

You have been diagnosed with dementia in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tight or routine intraoperative blood pressure management during surgery

During surgery

Postoperative Monitoring

Participants are monitored for major perfusion-related complications and other outcomes

30 days

Follow-up

Participants are monitored for cognition and major adverse cardiac events

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Routine pressure management
• Tight pressure management
• Vasopressor

Trial Overview

This trial tests two ways to manage blood pressure during major surgery: 'tight' management aims to keep intraoperative mean arterial pressure (MAP) ≥85 mmHg using norepinephrine or phenylephrine infusions; 'routine' management follows standard care without this strict MAP target.

How Is the Trial Designed?

Group I: Tight blood pressure management Experimental Treatment 1 Intervention

In patients assigned to tight blood pressure control, angiotensin converting enzyme inhibitors and angiotensin receptor blockers will not be given the morning of surgery. Other chronic antihypertensives will only be given as necessary to treat hypertension. Norepinephrine or phenylephrine infusion will be infused at a rate sufficient to maintain intraoperative MAP ≥ 85 mmHg.

Group II: Routine blood pressure management Experimental Treatment 1 Intervention

ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Hypertension is a common issue in surgical patients, often caused by systemic vasoconstriction, which can negatively impact surgical outcomes, making preoperative evaluation crucial.

Effective preoperative treatments for hypertension include oral beta-blockers and alpha2-adrenergic antagonists, while fast-acting agents like sodium nitroprusside and esmolol are used during and after surgery to manage hypertensive emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for managing perioperative hypertension. Goldberg, ME., Weaver, FA.[2008]

Continue antihypertensive medications up to the morning of surgery to maintain blood pressure control, ensuring the dose is taken with a small sip of water.

Aim to adjust antihypertensive therapy to achieve a blood pressure of less than 160/90 mm Hg for at least two weeks before surgery to reduce surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative hypertension. The primary care physician's role. Thompson, D., Ampel, L.[2019]

In a study of 27 hypertensive patients undergoing anesthesia, the type of antihypertensive medication (clonidine, methyldopa, or reserpine) did not significantly affect blood pressure or heart rate changes during surgery.

Hypokalemia was identified as the most common postoperative complication across all groups, indicating a need for monitoring potassium levels in hypertensive patients undergoing anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulatory changes during and after surgical anesthesia in hypertensive patients treated with clonidine, methyldopa and reserpine. Ryhänen, P., Hanhela, R., Jouppila, R., et al.[2013]

Periprocedural hypertension is common in patients undergoing vascular surgery and can increase the risk of cardiovascular complications, so managing blood pressure is crucial for improving surgical outcomes.

Surgery should not be canceled unless blood pressure exceeds 180 mm Hg systolic or 110 mm Hg diastolic, and preoperative antihypertensive medications should typically be continued; however, oral nifedipine should be avoided postoperatively due to risks of severe hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periprocedural hypertension: current concepts in management for the vascular surgeon. Samson, RH.[2017]

Continuing antihypertensive therapy up to the date of surgery significantly reduces perioperative risks for patients with hypertension, highlighting the importance of managing blood pressure before and during surgical procedures.

Effective collaboration among internists, surgeons, and anesthesiologists is crucial for safely managing hypertensive patients during operations, ensuring careful selection of anesthetics and continuous patient monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hypertension and surgical risk]. Hoffmann, D.[2007]

In a study of 14 pediatric patients undergoing surgery for congenital heart disease, clevidipine effectively controlled blood pressure (BP) during the perioperative period, achieving target BP within 5 minutes of administration.

However, clevidipine was not effective in controlling mean arterial pressure (MAP) during cooling and cardiopulmonary bypass, indicating limitations in its use during specific surgical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clevidipine for perioperative blood pressure control in infants and children undergoing cardiac surgery for congenital heart disease. Tobias, JD., Schechter, WS., Phillips, A., et al.[2021]

Hypertensive patients should avoid using adrenergic agents for blood pressure control, with nasal phenylephrine hydrochloride being the safest option among them, while pseudoephedrine may also be safe.

Ibuprofen can raise blood pressure if taken at maximum over-the-counter doses for extended periods, highlighting the need for caution with nonprescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonprescription drugs and hypertension. Which ones affect blood pressure? Bradley, JG.[2019]

Perioperative hypertension is common in surgical patients and can lead to complications like hematoma, particularly after facelift surgery, necessitating careful blood pressure management with target goals of <150 mm Hg systolic and >65 mm Hg diastolic.

The article reviews effective treatment strategies for managing perioperative hypertension across different surgical phases, including the use of antihypertensive medications preoperatively and IV hypnotics intraoperatively, to ensure patient safety during procedures without anesthesiologist support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Hypertension Management during Facelift under Local Anesthesia with Intravenous Hypnotics. Chung, KH., Cho, MS., Jin, H.[2020]

Postoperative hypotension is common in ICU patients after noncardiac surgery and is linked to serious complications such as myocardial infarction, acute kidney injury, and even death, suggesting it may be a modifiable risk factor.

Despite the association between hypotension and adverse outcomes, there is still insufficient evidence to confirm a direct causal relationship, highlighting the need for further research to determine if managing blood pressure can improve postoperative results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative blood pressure management in patients treated in the ICU after noncardiac surgery. Briesenick, L., Flick, M., Saugel, B.[2021]

Intra-arterial blood pressure monitoring in 4342 patients undergoing noncardiac surgery was associated with a higher incidence of peri-operative myocardial injury (38.7%) compared to noninvasive monitoring (25.7%), indicating a potential increased risk of morbidity.

Even after adjusting for various patient and surgical factors, intra-arterial monitoring remained linked to a greater risk of myocardial injury, suggesting that this method may not improve outcomes and could warrant further investigation in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mode of blood pressure monitoring and morbidity after noncardiac surgery: A prospective multicentre observational cohort study. Abbott, TEF., Howell, S., Pearse, RM., et al.[2023]

Perioperative hypertension is a common issue during surgery, but there is no standardized method for assessing intraoperative hemodynamics, leading to variability in treatment approaches.

Management of perioperative hypertension should be tailored to each patient, as there is no consensus on treatment thresholds or targets, highlighting the need for individualized therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative hypertension management. Varon, J., Marik, PE.[2022]

Clevidipine was successfully used as the sole agent for managing intraoperative blood pressure in two adult patients undergoing surgery for pheochromocytoma, a rare tumor that causes excessive catecholamine production.

The use of clevidipine provided effective and predictable blood pressure control, which is crucial for preventing serious complications during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Use of Clevidipine for Intraoperative Blood Pressure Management in Patients With Pheochromocytoma. Lindstrom, EJ., Attaallah, AF.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10660199/

Tight perioperative blood pressure management to reduce ...

Tight BP management markedly increased intraoperative MAP and reduced the amount of hypotension. In contrast, delaying chronic antihypertensive medications had ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091224002642

PeriOperative Quality Initiative (POQI) international ...

This article presents updated consensus statements and recommendations on perioperative arterial pressure management developed during the 11th POQI ...

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ahajournals.org

ahajournals.org/doi/10.1161/HYP.0000000000000249

2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ ...

An increasing number of individual studies and meta-analyses of observational data have reported a gradient of higher CVD risk from normal BP, ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05416944

Study Details | NCT05416944 | Perioperative Personalized ...

Rates of major complications and mortality in the first weeks after surgery remain very high: postoperative mortality is still around 2% in central Europe ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40962376/

Intensive vs Conventional Intraoperative Blood Pressure ...

Objectives: The purpose of this study was to determine whether intensive intraoperative blood pressure management reduces the incidence of a ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S073510972507250X/pdf

Intensive vs Conventional Intraoperative Blood Pressure ...

Patients assigned to intensive intraoperative blood pressure management experienced a lower burden of hypotension exposure, as assessed by ...

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journals.lww.com

journals.lww.com/cmj/fulltext/2025/01200/intraoperative_targeted_blood_pressure_management.18.aspx

Intraoperative targeted blood pressure management and...

With regard to safety outcomes, the patients assigned to targeted blood pressure management developed less severe intraoperative hypotension ...

8.

bjanaesthesia.org

bjanaesthesia.org/article/S0007-0912(24)00264-2/fulltext

PeriOperative Quality Initiative (POQI) international ...

This article presents updated consensus statements and recommendations on perioperative arterial pressure management developed during the 11th POQI ...

9.

bmjopen.bmj.com

bmjopen.bmj.com/content/bmjopen/13/11/e071328.full.pdf

Tight perioperative blood pressure management to reduce ...

Conclusions Tight BP management markedly increased intraoperative MAP and reduced the amount of hypotension. In contrast, delaying chronic.