Angiotensin II in General Anesthesia

What Was Tested

The trial (phase 4) is built around Angiotensin II.

Hypotension in adult patients undergoing general anesthesia is common.

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).

It had three arms (groups): Participants on ACE inhibitors (experimental), Participants on ARBs (experimental) and Other Classes of Antihypertensive Agents (experimental).

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

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

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

The registry classes the interventions as drug.

More on the Plan

Vasodilation also plays a key role in hypotension due to general anesthesia.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: BMI \> 40; history of deep venous thrombosis / thromboembolic disease; history of stroke,.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Angiotensin II was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-10-03 with completion listed for 2023-03-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 14 secondary outcomes, for example Median Serum Level of Bradykinin 1-8, Median Serum Level of Bradykinin 1-7, Median Serum Level of Bradykinin 1-5, Median Serum Level of Aldosterone, Median Serum Level of Angiotensin I and Median Serum Level of Angiotensin II.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Angiotensin II in 32 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Angiotensin II compound page, all human trials.