Analysis of the Clinical Efficacy of Intravenous Application of Hemostatic Drugs in Improving the Clarity of Vision Under Endoscope, Perioperative Bleeding Volume and Anti-inflammatory Effect of Spinal Endoscopic Lumbar Fusion

What Was Tested

The trial (phase 4) is built around Desmopressin.

It had three arms (groups): Caroxime sodium sulfonate (experimental), Desmopressin (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

A total of 129 patients diagnosed with lumbar spondylolisthesis and undergoing endoscopic lumbar fusion in their hospital from February 2024 to February 2025 were prospectively enrolled in this trial.

All subjects who met the inclusion criteria were enrolled in the trial after signing the informed consent form.

After completing the relevant information registration, routine preoperative preparation was performed and relevant baseline data were collected.

The randomization scheme was completed by specialized statisticians independently and was not affected by the subjective will of the researchers and the subjects.

Who Took Part

126 planned participants were the target.

It was open to people of any sex aged from 35 years up to 65 years.

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

Examples of who could join: Patients, aged 35-65 years old, who were diagnosed as single-segment lumbar spondylolisthesis without spondylolysis based on imaging data and underwent endoscopic lumbar interbody fusion. In patients with normal platelet count, blood coagulation function. No history of major lumbar trauma and previous lumbar surgery. No allergy history, contraindications and serious adverse reactions to desmopressin and carosodiumsulfonate. American Society of Anesthesiologists (ASA) classification: grade 1-2.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: patients who do not consent to participate in the trial; poorly controlled hypertension with systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg; people with mental illness, or poor compliance of patients.

How the Study Was Run

Design: randomized, parallel-group and single-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.

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

In this single-blind Desmopressin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2024-03-28 with completion listed for 2024-12-30.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clarity under microscope (time frame: During the operation). Total Blood Loss（TBL） (time frame: During the operation). Intraoperative Blood Loss（IBL） (time frame: During the operation).

It also tracked 4 secondary outcomes, for example Erythrocyte sedimentation Rate（ESR）, Visual analogue scale, IL--6 and C-reactive protein.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 126 people.

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

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