Randomized Controlled Clinical Study on the Prophylactic Intraoperative Use of Desmopressin in Complex Sellar Region Tumors

What Was Tested

This registered phase 4 trial tested Desmopressin.

DI can lead to hypernatremia, and the rapid elevation of serum sodium within hours can precipitate acute brain tissue shrinkage, potentially resulting in devastating complications including intracerebral hemorrhage, cerebral venous sinus thrombosis, seizures, somnolence, and coma.

Furthermore, dehydration secondary to DI may compromise organ perfusion and enhance anaerobic glycolysis in tissues, leading to hyperlactatemia and even lactic acidosis.

It had two arms (groups): Intervention group (experimental) and Control group (placebo comparator).

Receiving prophylactic dDAVP treatment during surgery.

Not receiving prophylactic dDAVP treatment.

The registry classes the interventions as drug and other.

Who Took Part

152 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Preoperatively confirmed central diabetes insipidus (CDI);. Maximum tumor diameter \> 3 cm with imaging evidence of suprasellar extension;. Imaging evidence of close anatomical relationship with the pituitary stalk, posterior pituitary, or hypothalamus, including compression, encasement, or invasion;.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: (1) patients with pre-existing comorbidities affecting water and salt metabolism, including but not limited to:; untreated adrenal insufficiency (cortisol deficiency impairs free water excretion);.

How the Study Was Run

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

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

The Desmopressin group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Desmopressin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-06-02 with completion listed for 2028-05-01.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of hypernatremia within the first 24 hours postoperatively (time frame: Up to 24 hours postoperatively).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 152 people.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

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