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

Region Hovedstaden0 个研究点目标入组 30 人开始时间: 2017年10月27日最近更新: 2018年2月26日

试验速览

暂无简介。

•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

•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.

发起方

Region Hovedstaden