Blood Pressure Management During Surgery for High Blood Pressure

Recruiting at 15 trial locations

Overseen By Fabio Rodriguez Patarroyo, 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

Trial Summary

What is the purpose of this trial?

The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management).

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.

What data supports the effectiveness of blood pressure management treatments during surgery for high blood pressure?

Research suggests that managing blood pressure during and after surgery is crucial to prevent complications. Continuing antihypertensive therapy (medications to lower blood pressure) up to the day of surgery and maintaining blood pressure below certain levels before surgery can reduce surgical risks. ^{1 2 3 4 5}

Is blood pressure management during surgery safe for humans?

Blood pressure management during surgery is generally considered safe when carefully monitored, as seen in the use of clevidipine for controlling blood pressure in both adults and children during surgery. However, continuous monitoring and appropriate drug selection are crucial to avoid complications. ^{4 6 7 8 9}

How does the blood pressure management treatment during surgery differ from other treatments?

This treatment is unique because it involves tight control of blood pressure during surgery using specific medications like norepinephrine and phenylephrine, which are vasopressors (drugs that tighten blood vessels to raise blood pressure). This approach is more intensive compared to standard management and aims to maintain stable blood pressure, reducing the risk of complications during and after surgery. ^{3 4 10 11 12}

Research Team

Daniel I Sessler, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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 am scheduled for brain surgery.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Tight 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 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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mode of blood pressure monitoring and morbidity after noncardiac surgery: A prospective multicentre observational cohort study. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Perioperative hypertension management. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Postoperative blood pressure management in patients treated in the ICU after noncardiac surgery. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Hypertension and surgical risk]. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Perioperative hypertension. The primary care physician's role. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Perioperative Hypertension Management during Facelift under Local Anesthesia with Intravenous Hypnotics. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Novel Use of Clevidipine for Intraoperative Blood Pressure Management in Patients With Pheochromocytoma. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Clevidipine for perioperative blood pressure control in infants and children undergoing cardiac surgery for congenital heart disease. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Strategies for managing perioperative hypertension. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. Italy pubmed.ncbi.nlm.nih.gov

Circulatory changes during and after surgical anesthesia in hypertensive patients treated with clonidine, methyldopa and reserpine. [2013]