Angiotensin II in General Anesthesia

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Angiotensin II

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03733145

HL-051952 (Other Grant/Funding Number)

IRB00054661

AG070371 (Other Grant/Funding Number)

Details and patient eligibility

About

Hypotension in adult patients undergoing general anesthesia is common. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors (ACE) and Angiotensin Receptor Blockers (ARBs). Intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.

Full description

Hypotension in adult patients undergoing general anesthesia is common. Many of the body's normal mechanisms to maintain adequate blood pressure in the non-anesthetized state are significantly altered by anesthetic agents, which may lead to hypotension. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. In response to this it has become standard of care to attempt to maintain blood pressure levels within 20% of baseline in most patients under anesthesia. Maintaining the baseline blood pressure is important as patients may have pathology such as coronary artery disease, carotid stenosis, and renal artery stenosis, and hypotension may compromise the perfusion of these organs. Vasodilation also plays a key role in hypotension due to general anesthesia. Therefore, the intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.The objective of this study is to determine the infusion rate of Ang II that is necessary to return systolic blood pressure (SBP) to within 5% of baseline or greater in patients with essential hypertension taking ACE inhibitors, ARBs, or different classes of antihypertensive agents and further to determine the plasma levels of different RAAS components

Enrollment: 32 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of hypertension and treatment with at least one medication including an ACE inhibitor, ARB, and other agents for greater than 2 months
• Patients undergoing general anesthesia

Exclusion criteria

• BMI > 40
• History of deep venous thrombosis / thromboembolic disease
• History of stroke,
• Baseline SBP of ≥ 160 mmHg,
• History of myocardial infarction or cardiac stents
• Difficult airway
• Asthma
• Congestive heart failure
• Chronic obstructive pulmonary disease
• Pregnant patients

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Participants on ACE inhibitors

Experimental group

Description:

Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.

Treatment:

Drug: Angiotensin II

Participants on ARBs

Experimental group

Description:

Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.

Treatment:

Drug: Angiotensin II

Other Classes of Antihypertensive Agents

Experimental group

Description:

Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.

Treatment:

Drug: Angiotensin II