A comparison of dexmedetomidine vs placebo effect on sleep-quality in mechanical ventilated critical ill patients

A COMPARISON OF DEXMEDETOMIDINE VS PLACEBO AFFECT ON SLEEP-QUALLITY IN MECHANICAL VENTILATED CRITICAL ILL PATIENTS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001612-11-DK

Enrollment

Registered

2017-10-27

Start date

2018-01-11

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleeping problems in mechanical ventilated critical ill patients in ICU MedDRA version: 20.0 Level: PT Classification code 10053319 Term: Sleep study System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Dexdor Product Name: Dexdor Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: dexmedetomidine hydrochloride CAS Number: 145108-58-3 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Admitted to an ICU • = 18 years • Anticipated stay in the ICU for another day after sleep recording including patients in mechanically ventilated •Hemodynamically stable •Concious non sedated patients with Danish language Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Patients who are awake and conscious with a SOFA score over 12 • Post operative patients • Trauma patients • Structual neurologic diseases (e.g. stroke, tumor), degenerative (e.g.Parkinsons disease, dementias), seizure, infectios or other disorders affecting the brain based on critical history of epilepsi • Major psychiatric disorder: schizophrenia, severe depression • Second or third degree atrionventricular block (unless pacemaker inplanted) • Positive pregnancy test or currently lactating/ known pregnancy or lactation • Severe agitated delirium at the time of inclusion • High risk of death in the study period due to concomitant disease. • Use of other alpha-2 agonists (clonidine) during ICU stay • Patients with limitations in therapy • Participation in other study involving use of a pharmacologically active compound • Otherwise unable to fulfill the study, according to investigator´s opinion.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does dexmedetomidine improve deep sleep/sleep quality compared to placebo. ;Secondary Objective: Does dexmedetomidine compared with placebo affect on a) sleep phases, b) daytime function, including anxiety and delirium, ;Primary end point(s): Improvement of deep sleep/sleep quality of clinical significance will be determined by slow wave activities using PolySomnoGraphy (PSG);Timepoint(s) of evaluation of this end point: Continues measurement of sleep deept with a PolySomnoGraphy (PSG) during the study	—

Measure

Time frame

Main Objective: Does dexmedetomidine improve deep sleep/sleep quality compared to placebo. ;Secondary Objective: Does dexmedetomidine compared with placebo affect on a) sleep phases, b) daytime function, including anxiety and delirium, ;Primary end point(s): Improvement of deep sleep/sleep quality of clinical significance will be determined by slow wave activities using PolySomnoGraphy (PSG);Timepoint(s) of evaluation of this end point: Continues measurement of sleep deept with a PolySomnoGraphy (PSG) during the study

—

Secondary

Measure	Time frame
Secondary end point(s): d) Sleep phases will be determined by PSG e) Daytime function including anxiety and delirium determined by Cam ICU and alertness and wakeness determined by RASS ;Timepoint(s) of evaluation of this end point: Continues measurement during the study	—

Countries

Denmark

Contacts

Public ContactPoul Jennum

Region Hovedstaden

poul.jennum@regionh.dk+4538632512

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026