NCT03335527

Impacts of Low-Dose Dexmedetomidine on Sleep Quality in Mechanically Ventilated ICU Patients

Completed Phase 4 Last updated 11 December 2019

What this trial tests

Phase 4 trial testing Dexmedetomidine in Aged in 80 participants. Completed in 30 November 2019.

Timeline

17 November 2017

Primary endpoint
31 October 2019

30 November 2019

Quick facts

Lead sponsor	Peking University First Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	80
Start date	17 November 2017
Primary completion	31 October 2019
Estimated completion	30 November 2019
Sites	1 location across China

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Placebo (normal saline)

Conditions studied

• Aged — all drugs for Aged →
• Postoperative Period — all drugs for Postoperative Period →
• Intensive Care Units — all drugs for Intensive Care Units →
• Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →

Sponsor

Peking University First Hospital

Who can join

18 and older, any sex, with Aged or Postoperative Period. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep disturbances frequently occur in intensive care unit (ICU) patients undergoing mechanical ventilation. In a previous study, sedative dose dexmedetomidine (median 0.6 microgram/kg/h) improved sleep quality in mechanically ventilated patients. However, for mechanically ventilated patients, 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, non-sedative low-dose dexmedetomidine (0.1 microgram/kg/h) improved sleep quality in non-mechanically ventilated elderly patients admitted to the ICU after surgery. The investigators hypothesize that, in mechanically ventilated patients who are admitted to the ICU after surgery, low-dose dexmedetomidine may also improve sleep quality.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of low-dose dexmedetomidine on sleep quality in postoperative patients with mechanical ventilation in the intensive care unit: A pilot randomized trial.
   Sun YM, Zhu SN, Zhang C, Li SL, et al · · 2022 · cited 13× · PMID 36117973 · DOI 10.3389/fmed.2022.931084