Status:
COMPLETED
Impacts of Low-Dose Dexmedetomidine on Sleep Quality in Mechanically Ventilated ICU Patients
Lead Sponsor:
Peking University First Hospital
Conditions:
Aged
Postoperative Period
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 sle...
Detailed Description
Sleep is severely disturbed in mechanically ventilated ICU patients, especially those after surgery. Polysomnographic studies performed in these patients demonstrated a severe increase in sleep fragme...
Eligibility Criteria
Inclusion
- aged 18 years or older;
- admitted to the ICU after surgery;
- with an expected duration of mechanical ventilation of more than 12 hours (admitted before 21:00 on the day of surgery and extubated after 06:00 on the first day after surgery).
Exclusion
- refused to participate;
- aged less than 18 years;
- pregnant;
- preoperative history of schizophrenia, epilepsy, parkinsonism, or myasthenia gravis;
- inability to communicate in the preoperative period (coma, profound dementia, or language barrier);
- brain injury or neurosurgery;
- known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (\<50 beats per min), or second degree or greater atrioventricular block without pacemaker, systolic blood pressure less than 90 mmHg despite continuous infusions of vasopressors before the start of study drugs infusion;
- serious hepatic dysfunction (Child-Pugh class C);
- serious renal dysfunction (undergoing dialysis before surgery);
- less likelihood to survive for more than 24 hours;
- preoperative history of sleep disorders (requirement of hypnotics/sedatives during the last month) or history of obstructive sleep apnea syndrome (diagnosed with obstructive sleep apnea);
- allergy to the study drugs;
- other conditions that are considered unsuitable for study participation.
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03335527
Start Date
November 17 2017
End Date
November 30 2019
Last Update
December 11 2019
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034