Blood Pressure Management During Surgery for High Blood Pressure
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
Must be taking: Antihypertensives
Disqualifiers: Carotid, Intracranial, Nephrectomy, Dementia, others
No Placebo Group
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.12345
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.46789
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.34101112
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.
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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.
See 9 more
Trial 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 (Procedure)
- Tight pressure management (Procedure)
- Vasopressor (Vasopressor)
Trial OverviewThis 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
2Treatment groups
Experimental Treatment
Group I: Tight pressure managementExperimental Treatment1 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 managementExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic Fairview HospitalCleveland, OH
Cleveland ClinicCleveland, OH
MetroHealth Medical CenterCleveland, OH
Wake Forest UniversityWake Forest, NC
More Trial Locations
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
References
Mode of blood pressure monitoring and morbidity after noncardiac surgery: A prospective multicentre observational cohort study. [2023]Control of blood pressure remains a key goal of peri-operative care, because hypotension is associated with adverse outcomes after surgery.
Perioperative hypertension management. [2022]Perioperative hypertension is commonly encountered in patients that undergo surgery. While attempts have been made to standardize the method to characterize the intraoperative hemodynamics, these methods still vary widely. In addition, there is a lack of consensus concerning treatment thresholds and appropriate therapeutic targets, making absolute recommendations about treatment difficult. Nevertheless, perioperative hypertension requires careful management. When treatment is necessary, therapy should be individualized for the patient. This paper reviews the pharmacologic agents and strategies commonly used in the management of perioperative hypertension.
Postoperative blood pressure management in patients treated in the ICU after noncardiac surgery. [2021]Blood pressure management is a cornerstone of hemodynamic management in patients treated in the ICU after noncardiac surgery. Postoperative blood pressure management is challenging, because blood pressure alterations after surgery can be profound and have numerous causes.
[Hypertension and surgical risk]. [2007]The perioperative risk of the patients with hypertension improves when the antihypertensive therapy is continued to the date of operation and a differentiated selection of narcotics and narcosis adjuvants as well as a careful narcotization is performed. In these cases the continuous control of the patient is necessary. In case of an operative intervention hypertension must be reason for the interdisciplinary cooperation between internist, surgeon and anaesthesiologist.
Perioperative hypertension. The primary care physician's role. [2019]Questions concerning the proper management of hypertension in surgical patients often arise in primary care practice. Currently available literature and our own clinical experience lead us to make the following recommendations. 1. Continue antihypertensive therapy up to and including the morning of surgery, when the dose should be given with a small sip of water. 2. If possible, adjust antihypertensive therapy so blood pressure is less than 160/90 mm Hg for at least two weeks prior to surgery. 3. Discontinue all monoamine oxidase inhibitors at least one week prior to surgery and substitute alternative antihypertensive or antidepressant medication as necessary. 4. Be attentive to the patient's preoperative volume status and any evidence of cardiovascular disease. 5. In patients with postoperative hypertension, search for specific aggravating factors and treat them primarily. 6. Discuss with the anesthesiologist any difficulties in blood pressure control.
Nonprescription drugs and hypertension. Which ones affect blood pressure? [2019]Hypertensive patients should be aware of the possible effects of nonprescription medications on blood pressure control. For absolute safety, no adrenergic agents should be used. Nasal phenylephrine hydrochloride is probably the safest of these agents, and pseudoephedrine hydrochloride may also be safe. Phenylpropanolamine hydrochloride and ephedrine sulfate are probably best avoided. The effects of other adrenergic agents (eg, epinephrine) on blood pressure have not been clinically evaluated. Ibuprofen may elevate blood pressure if taken in maximum over-the-counter doses for more than a few days. The ethanol and sodium chloride content of nonprescription drugs taken in recommended doses does not appear to pose a great hazard.
Perioperative Hypertension Management during Facelift under Local Anesthesia with Intravenous Hypnotics. [2020]Perioperative hypertension is a phenomenon in which a surgical patient's blood pressure temporarily increases throughout the preoperative and postoperative periods and remains high until the patient's condition stabilizes. This phenomenon requires immediate treatment not only because it is observed in a majority of patients who are not diagnosed with high blood pressure, but also because occurs in patients with underlying essential hypertension who show a sharp increase in their blood pressure. The most common complication following facelift surgery is hematoma, and the most critical risk factor that causes hematoma is elevated systolic blood pressure. In general, a systolic blood pressure goal of 65 mm Hg are recommended. This article discusses the causes of increased blood pressure and the treatment methods for perioperative hypertension during the preoperative, intraoperative, and postoperative periods, in order to find ways to maintain normal blood pressure in patients during surgery. Further, in this paper, we review the causes of perioperative hypertension, such as anxiety, epinephrine, pain, and postoperative nausea and vomiting. The treatment methods for perioperative hypertension are analyzed according to the following 3 operative periods, with a review of the characteristics and interactions of each drug: preoperative antihypertensive medicine (atenolol, clonidine, and nifedipine), intraoperative intravenous (IV) hypnotics (propofol, midazolam, ketamine, and dexmedetomidine), and postoperative antiemetic medicine (metoclopramide and ondansetron). This article focuses on the knowledge necessary to safely apply local anesthesia with IV hypnotics during facelift surgery without the assistance of an anesthesiologist.
Novel Use of Clevidipine for Intraoperative Blood Pressure Management in Patients With Pheochromocytoma. [2019]Pheochromocytomas are rare tumors that produce excessive epinephrine and norepinephrine, leading to multiple manifestations of catecholamine surges. Acute intraoperative hypertension during pheochromocytoma resection requires prompt control to avoid major and potentially lethal cardiac and neurologic complications. This article reports the planned and successful use of clevidipine (Cleviprex) as the "sole agent" for intraoperative blood pressure management in 2 adult patients with a diagnosis of pheochromocytoma undergoing elective open adrenalectomy. Clevidipine effectively and promptly provided predictable blood pressure control in both patients.
Clevidipine for perioperative blood pressure control in infants and children undergoing cardiac surgery for congenital heart disease. [2021]To determine the efficacy and adverse effect profile of clevidipine when used for perioperative blood pressure (BP) control during surgery for congenital heart disease (CHD).
Strategies for managing perioperative hypertension. [2008]Hypertension is a pervasive and growing health concern. The occurrence of hypertension due to systemic vasoconstriction in patients before, during, and after surgery is not uncommon and can have serious consequences with regard to outcomes. Careful evaluation prior to surgery to identify the underlying cause of hypertension is important in selecting the best treatment option. Preoperative treatment options include oral beta-adrenergic receptor blockers, alpha2-adrenergic receptor antagonists, and in the case of hypertensive emergencies, the fast-acting parenteral agents sodium nitroprusside, the intravenous beta-adrenergic receptor blocker esmolol, and nicardipine. Therapeutic options during and after surgery include sodium nitroprusside, esmolol, and nicardipine, among others.
Periprocedural hypertension: current concepts in management for the vascular surgeon. [2017]Periprocedural hypertension is a common finding in patients undergoing vascular surgery or endovascular procedures, and this may pose a risk for subsequent cardiovascular morbidity or mortality. Accordingly, the vascular surgeon who wishes to improve outcomes needs to be proficient not only in surgical technique but also in the medical management of the patient's associated conditions, especially hypertension. Vascular procedures need not be cancelled unless the blood pressure (BP) is more than 180 mm Hg systolic or 110 mm Hg diastolic, but attention should also be paid to evidence of end organ damage in making this decision. In most cases preoperative antihypertensive medications should be continued up till the procedure. Postoperative hypertension may require 1 of a number of intravenous medications, which are listed. Oral nifedipine should generally be avoided for fear of inducing an uncontrolled hypotensive response and cardiac ischemia.
Circulatory changes during and after surgical anesthesia in hypertensive patients treated with clonidine, methyldopa and reserpine. [2013]The cardiovascular changes in 27 hypertensive patients belonging to WHO classes I-II and treated with either clonidine, methyldopa or reserpine during thiopentone-N2O-O2-relaxant-analgesic anesthesia were studied. The variations in systolic and diastolic blood pressure and heart rate during induction of anesthesia and surgery did not differ according to the antihypertensive drug with which the patient was treated. Hypokalemia was found to be the most common postoperative complication in all study groups. The results suggest that the selection of antihypertensive drug does not form a risk factor when hypertensive patients are being prepared for anesthesia and surgery.