Sleep Disorder
Conditions
Interventions
Remimazolam group:Continuous intravenous infusion of remimazolam. Polysomnography (PSG) was used to monitor patients' sleep, and patients' vital signs were recorded. The infusion of sedative-hypnotic
Dexmedetomidine group:Continuous intravenous infusion of dexmedetomidine. Polysomnography (PSG) was used to monitor patients' sleep, and vital signs were recorded. Infusion of sedative-hypnotic drugs
Placebo control group:Continuous intravenous infusion of placebo (50ml of 0.9% NaCl) . Polysomnography (PSG) was used to monitor the patients' sleep, and their vital signs were recorded. Infusion of s
Sponsors
The First Affiliated Hospital of Naval Medical University (Changhai Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years old; 2. Patients who have been weaned off ventilator support after cardiac surgery in the ICU; 3. Patients with hemodynamic stability before inclusion in the study; 4. Patients who have stopped infusion of sedatives for 12 hours or more; 5. The absolute sum of the doses of vasoactive drugs used by patients does not exceed 15 (see description later); 6. Obtain informed consent from the patient.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from this series of studies if they meet any of the following criteria: 1. Age 75 years; 2. Presence of delirium at the time of study enrollment; 3. Use of any sedative medication within 12 hours prior to the start of the study; 4. Patients requiring antipsychotic or antidepressant medication; 5. Presence of any neurological disease that may significantly affect sleep quality, such as psychiatric disorders, hypoxic brain injury, suspected encephalopathy (due to drug overdose, liver failure, or renal failure), intracranial infection, or a history of epilepsy; 6. History of sleep apnea, history of sleep disorders, or a history of daily use of sleep medications; 7. Glasgow Coma Scale score 15, or Sequential Organ Failure Assessment (SOFA) score >8; 8. Severe bradycardia (heart rate <50 beats per minute) or presence of II-III degree heart block (excluding those with a pacemaker implanted), severe hypotension (MAP <50 mmHg; systolic blood pressure <90 mmHg despite vasopressor support); 9. Severe pre-existing liver disease with clinically significant portal hypertension, Child-Pugh C class cirrhosis, or acute liver failure; 10. Pregnant or lactating women; 11. Known history of allergy to any study drug or presence of other contraindications; 12. Patients participating in other studies involving the use of active pharmaceutical ingredients. 13. Patients with chronic renal insufficiency requiring long-term dialysis; 14. Subjects deemed by the investigator to be unable to participate in subsequent follow-up; 15. Refusal of treatment or automatic discharge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of each stage of non-rapid eye movement sleep (NREM);REM sleep duration;Total sleep duration;Number of sleep-wake cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| Delirium incidence rate;Sleep efficiency;Respiratory events during sleep (apnea + hypopnea frequency);Subjective Sleep Quality Comparison (Ritz Sleep Questionnaire LSEQ);Drug Safety Indicators; | — |
Countries
China
Contacts
Public ContactLi Bailing
The First Affiliated Hospital of Naval Medical University (Changhai Hospital)
Outcome results
None listed