Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery

What Was Tested

The trial (phase 4) is built around Desmopressin.

This study was conducted to evaluate the effect of desmopressin on blood loss and the quality of the surgical field in FESS.

It had two arms (groups): Desmopressin (experimental) and saline (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Desmopressin, a synthetic analogue of vasopressin, has been employed as a non-transfusional treatment for hemophilia and von Willebrand's disease.

Randomized, double-blind studies have been performed on patients undergoing various types of surgical procedures.

The purpose of this study was to investigate the effect of administration of desmopressin on intraoperative blood loss in patients undergoing FESS.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: American Society of Anesthesiologists physical status I-II. Aged 18-60 years.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: patients receiving anticoagulants; medically important liver or kidney dysfunction; allergy to desmopressin.

How the Study Was Run

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

The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.

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

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

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2014-01 with completion listed for 2014-08.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Blood loss (time frame: During Functional Endoscopic Sinus Surgery of each patient).

It also tracked 1 secondary outcome, for example Quality of the surgical field using a scoring scale.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 60 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.