Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty

What Was Tested

In this not phased trial, researchers set out to test Terlipressin.

It had three arms (groups): control (active comparator), noradrenaline (active comparator) and glypressin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Hypovolemia is a common problem in many clinical situations.

The mortality of hypovolemic shock is directly related to the severity and duration of organ hypoperfusion.

Leg compression by flexion of the hip, elastic bandages, or stockings.

An efficient method to treat spinal hypotension is administration of vasopressors, either given by infusion or boluses.

Who Took Part

The registry lists 135 actual participants took part.

It was open to people of any sex aged from 40 years up to 65 years.

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

Examples of who could join: Adult Patients of both gender. American Society of Anesthesiologists (ASA) I or II. Scheduled for elective unilateral total knee arthroplasty.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: patient refusal; major cardiopulmonary disorders; uncontrolled systemic hypertension.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.

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

As a double-blind Terlipressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2022-12-01 with completion listed for 2023-06-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: change of mean arterial blood pressure (time frame: 30 minutes after tourniquet deflation).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 135 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Terlipressin compound page, all human trials.