CI

At a glance

ClinicalIndex Comparison Record
Phase 4Suspended· 260 target
Drug / intervention
Dexmedetomidine +1 moredrug
Likely dose
Dexmedetomidine 0.025 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03172897
NCT03172897Phase 4Suspended
Suspended

Low-dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Patients in Intensive Care Unit: a Multicenter, Randomised, Double-blinded, Placebo-controlled Trial

Peking University First Hospital·interventional·Posted Jun 1, 2017·Updated Jul 31, 2025

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine and Placebo (normal saline) for Adult Disease and 4 related conditions. Suspended, targeting 260 participants across 1 site.

Signals

Trial is currently suspended

Detailed Summary

For patients undergoing mechanical ventilation, light sedation is better than deep sedation for the outcomes, which is manifested as shortened length of ICU stay, shortened duration of mechanical ventilation, and decreased mortality. In a recent study of the investigators, low-dose dexmedetomidine without sedative effects (0.1 ug/kg/h) improved sleep quality and reduced the incidence of delirium in elderly patients admitted to the ICU after surgery. The investigators hypothesize that, for ICU patients with prolonged mechanical ventilation, low-dose dexmedetomidine infusion (0.1 ug/kg/h) may also be effective in decreasing delirium. The purpose of this study is to investigate whether low-dose dexmedetomidine infusion can reduce the incidence of delirium in ICU patients with prolonged duration of mechanical ventilation (\>= 24 hours).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 4SuspendedOverdue
201820192020202120222023202420252026
First PostedJun 1, 2017
Enrollment StartAug 20, 2017
Primary CompletionAug 21, 2017
Study CompletionDec 1, 2025
TodayJul 1, 2026
Enrollment to primary: 1 daysPosted 9.1 years ago

Interventions

Dexmedetomidinedrug

Dexmedetomidine is administered as a continuous intravenous infusion at a rate of 0.025 mL/kg per h (0.1 μg/kg per h) from study recruitment in the ICU for no more than 72 hours.

Placebo (normal saline)drug

Placebo (normal saline) is administered as a continuous intravenous infusion at a rate of 0.025 mL/kg per h from study recruitment in the ICU for no more than 72 hours.