Nasal Desmopressin Versus Oral Bisoprolol for Controlling Bleeding During Endoscopic Sinus Surgery

What Was Tested

The trial (phase 2) is built around Desmopressin.

Functional endoscopic sinus surgery (FESS) is well established for treatment of chronic rhinosinusitis and nasal polyps.

It had two arms (groups): Desmopressin group (Group D) (active comparator) and Bisoprolol group (group B) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The nasal mucosa at the site of surgery is very sensitive to sympathetic stimulation which Cause intraoperative hypertension and tachycardia.

It is also highly vascular and can bleed easily, so Compromise the visual clarity of the surgical field.

Desmopressin (1 deamino 8 D argininevasopressin) is a synthetic analog of the antidiuretic hormone L arginine vasopressin.

Bisoprolol, has the advantage of longer acting.

Who Took Part

100 actual participants took part.

It was open to people of any sex aged from 21 years up to 60 years.

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

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Desmopressin.

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

It started in 2022-07-01 with completion listed for 2022-10-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): the volume of blood loss in cubic centimeter (time frame: during surgeries).

It also tracked 1 secondary outcome, for example The quality of surgical field.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Desmopressin in 100 people.

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

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