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Dexmedetomidine for Prevention of Postoperative Delirium in Brain Tumor Patients

NCT04494828Phase 4

Key facts

Status: Completed
Start: Aug 2020
Primary completion: Dec 2020
Countries: 1
Sponsor: Capital Medical University
Modality: Small Molecules

Drugs: dexmedetomidine
Conditions: postoperative delirium (POD)

Overview

Phase 4, randomised, double-blind trial of dexmedetomidine in postoperative delirium (POD) (2 arms), sponsored by Capital Medical University. Primary endpoint: Incidence of study agent interruption during the study. Started Aug 2020; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Dexmedetomidine group
Dexmedetomidine 0.1 ug/kg/hour
Normal saline group
Placebo

Who it enrols

Adult patients after elective intracranial operation for brain tumor admitted to ICU. Excludes patients with severe bradycardia, heart block, low LVEF, severe hepatic/renal dysfunction, or history of mental/cognitive disorders.

Endpoints

Primary

Incidence of study agent interruption during the studyFrom start of infusion to postoperative day 1

Secondary

Time from the end of operation to randomizationUp to 24 hours post-operation
Duration of study agent infusionFrom start of infusion to postoperative day 1
Incidence of adverse eventsFrom start of infusion to 24 hours or ICU discharge
Non-delirium complicationsFrom start of infusion to postoperative day 28

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