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Dexmedetomidine improves sleep quality pattern in elder patients after head and neck tumor surgery: a randomized, double blind, controlled trial

Dexmedetomidine improves sleep quality pattern in elder patients after head and neck tumor surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051438
Enrollment
Unknown
Registered
2021-09-23
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Sleep Disorder

Interventions

Control group:infusion of 0.025 ml/kg/h saline
Experimental group:infusion of 0.3µg/kg/h dexmedetomidine

Sponsors

Fudan University Eye Ear Nose and Throat Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists classification (ASA classification) 1-2; 2. Laryngectomy under general anesthesia; 3. Patients admitted to the ICU before 20:00 pm.

Exclusion criteria

Exclusion criteria: 1. A history of schizophrenia, epilepsy or Parkinson's disease; 2. History of sleep disorders (hypnotics/sedatives taken within the last month); 3. History of obstructive sleep apnea syndrome; 4. Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate less than 50 beats/min) or atrioventricular block level two or above but no pacemaker; 5. Preoperative coma; 6. Brain injury or neurosurgery; 7. Severe liver dysfunction (Child-Pugh class C); 8. Severe renal insufficiency (preoperative dialysis); 9. Mechanically ventilated patients.

Design outcomes

Primary

MeasureTime frame
percentage of N1 sleep;percentage of N2 sleep;percentage of N3 sleep;percentage of rapid eye movement sleep;

Secondary

MeasureTime frame
Richmond AgitationSedation Scale score;The Confusion Assessment Method delirium score;Pain Numerical Rating Scale ;

Countries

China

Contacts

Public ContactShen Xia

Fudan University Eye Ear Nose and Throat Hospital

shenxia@eentanesthesia.com+86 21 64377134 2955

Outcome results

None listed

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