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Nocturnal dexmedetomidine alleviates post–intensive care syndrome following cardiac surgery

Nocturnal dexmedetomidine alleviates post–intensive care syndrome following cardiac surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076713
Enrollment
Unknown
Registered
2023-10-17
Start date
2019-01-20
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Cardiac disease

Interventions

Dexmedetomidine group:Dexmedetomidine
Control group:Normal saline

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patient age > 50 years; 2. Patients underwent scheduled cardiac surgery under general anesthesia with a planned ICU stay of at least 2 days; 3. The attending physician expected the patient to require sustained treatment with sedatives in order to ensure their comfort, safety, and sleep quality; 4. Patients or their legal representatives provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients that underwent emergency cardiac surgery; 2. New York Heart Association class ?or those with an ejection fraction ? 30%; 3. Patients with preexisting cognitive impairment as indicated by an MMSE score of = 26, a history of schizophrenia, epilepsy, or parkinsonism; 4. Patients with a proven or suspected history of severe stroke or other pathology that may result in anxiety, depression, or permanent or prolonged weakness; 5. Patients with preoperative sick sinus syndrome, severe sinus bradycardia (heart rate < 50 bpm), or atrioventricular block of second degree or above without pacemaker; 6. Patients with any known sensitivities to any of the study medications or the components of propofol (egg, soy, or peanut proteins), or patients with an allergy to a2-adrenergicagonist or opioids; 7. Patients suffering from preoperative coma; 8. Patients suffering from brain injury or undergoing neurosurgery; 9. Patients suffering from serious hepatic dysfunction (Child-pugh class C) or renal dysfunction (undergoing dialysis before surgery); 10. Patients for whom death is believed to be imminent or inevitable during admission and for whom either the attending physician, patient, or substitute decision maker is not committed to active treatment; 11. Patients previously recruited for other clinical trials; 12. Patients affected by blindness, deafness, an inability to comprehend standard Chinese, or active substance abuse and psychotic disorders were also excluded to facilitate reliable follow-up.

Design outcomes

Primary

MeasureTime frame
Post–intensive care syndrome ;Cognitive impair;Physical impair;Psychological impair;

Secondary

MeasureTime frame
Postoperative hospital stay duration;ICU stay duration;Mortality in hospitalization and following 6 months;Tracheal intubation time and retracheal intubation incidence;Acute kidney injury;Delirium after surgery;Sleep quality;ICU-acquired weakness after surgery;Safety endpoints(hypotension and bradycarida);Atrial fibrillation;Anxiety;Depression;PICS in 3 months;Extra fluid and vasoconstrictor intervention;

Countries

China

Contacts

Public ContactTanqi

Shandong Provincial Hospital

81453381@qq.com+86 187 5315 7303

Outcome results

None listed

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