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

NCT07712328 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-07-17

No results posted yet for this study

Summary

Craniopharyngiomas and giant invasive pituitary adenomas, with lesions originating from the pituitary stalk, are frequently associated with intraoperative and postoperative diabetes insipidus (DI). 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. However, the currently available evidence is insufficient to support the routine prophylactic anti-diuretic therapy during surgery.This study aims to evaluate the efficacy and safety of prophylactic low-dose continuous intravenous dDAVP infusion in patients undergoing surgery for complex sellar region lesions, with respect to reducing the incidence of hypernatremia occurring during surgery or within the first 24 hours postoperatively.

Conditions

  • Craniopharyngiomas
  • Pituitary Macroadenoma
  • Sellar and Suprasellar Masses

Interventions

DRUG

Desmopressin (DDAVP)

Desmopressin acetate (dDAVP) solution for injection, administered as a continuous intravenous infusion via syringe pump at a rate of 10mL/min (3.56 μg dDAVP diluted in 20ml normal saline)after Bony opening of the sella floor. The study intervention is compared to an equal volume of normal saline (0.9% NaCl) administered via the same route and regimen as placebo.

OTHER

Control

Not receiving prophylactic dDAVP treatment

Sponsors & Collaborators

  • Zhaoyun Zhang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-02
Primary Completion
2028-05-01
Completion
2028-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712328 on ClinicalTrials.gov