Sleep Disturbance
Conditions
Interventions
Nasal dexmedetomidine group:Intranasal dexmedetomidine hydrochloride 1.5 µg/kg (administered bilaterally) once nightly on postoperative days 1–4.
Control group:An equivalent volume of placebo was administered intranasally once nightly on postoperative days 1 - 4.
Sponsors
The Second Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. aged 18–65 years; 2. scheduled for isolated, elective heart-valve replacement requiring cardiopulmonary bypass; 3. able and willing to provide written informed consent; 4. body-mass index < 35 kg m?².
Exclusion criteria
Exclusion criteria: 1. History of alcohol or drug dependence; 2. Severe hepatic or renal impairment (Child-Pugh C or eGFR < 30 mL/min/1.73 m²); 3. Pregnancy, parturition, or emergency/urgent surgical indication; 4. Known contraindication to intranasal drug administration; 5. Inability to comprehend or cooperate with study assessments (language, cognitive, or physical limitation); 6. Obstructive sleep apnoea syndrome (AHI = 15 events/h or previously diagnosed); 7. Pre-operative ASA physical status = IV or NYHA functional class = IV; 8. Pre-existing neurological disease (stroke, epilepsy, dementia, hypoxic-ischemic brain injury, or neurodegenerative disorder); 9. Sick-sinus syndrome or second-/third-degree atrioventricular block (unpaced); 10. Diagnosed sleep disorder requiring pharmacological therapy prior to surgery; 11. Major depressive disorder or other psychiatric illness that, in the investigator’s opinion, could confound outcomes; 12. Any condition that, in the judgement of the investigator, renders the patient unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sleep quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Richards-Campbell Sleep Scale score ;SP-SQS;total sleep time;sleep efficiency;number of wakes;wake after sleep times;Incidence of delirium within 7 days after surgery;VAS score (at rest and coughing);Postoperative intensive care unit stay;Postoperative in-hospital all-cause mortality;QOR-15 score before discharge;PSQI score at 1 month;AD-8 score at 1 month;Short-form 36 score at postoperative 1 month; All-cause mortality one month after surgery;Incidence of chronic pain 3 months after surgery;AD-8 score at 3 months;PSQI score at 3 months;Short-form score at 3 months; | — |
Countries
CHINA
Contacts
Public ContactYang Guiying
The Second Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed