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Effect of remazolam on postoperative sleep quality in elderly patients undergoing thoracic surgery: a randomized controlled study

Effect of remazolam on postoperative sleep quality in elderly patients undergoing thoracic surgery: a randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074936
Enrollment
Unknown
Registered
2023-08-21
Start date
2023-08-15
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Postoperative sleep disturbance

Interventions

remazolam group:Propofol (2-4 mg/kg) was used for anesthesia induction and propofol (4-12 mg/kg/h) was used for anesthesia maintenance.
propofol group:Remazolam 0.2 to 0.3 mg/kg was used for anesthesia induction and remazolam 1.0 to 3.0 mg/kg/h for anesthesia maintenance

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age= 60 years old; 2. Patients who intend to undergo surgery for lung segment, lobe or total lung resection under elective general anesthesia. 3. The estimated end time of the operation is before 20:00

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; 2. Severe cardiac insufficiency (preoperative LVEF < 30% or NYHA grade IV); 3. Severe liver function abnormalities (Child-Pugh grade C); 4. Severe renal dysfunction (receiving dialysis before surgery); 5. ASA grade IV or above; 6. Allergy to study drugs; 7. Inability to communicate and cooperate due to severe dementia or language impairment before surgery.

Design outcomes

Primary

MeasureTime frame
Total sleep duration on the night of surgery;

Secondary

MeasureTime frame
Sleep efficiency, number of wakefulness and fragmentation index on the night of surgery;Total sleep duration, sleep efficiency, number of wakes and fragmentation index on the first and second nights after surgery;Subjective sleep quality score from the night of surgery to the night of the second day after surgery;Prefrontal-temporal brain network connection function before surgery, after loss of consciousness, and when consciousness is restored;Quality of sleep on day 30 postoperatively;

Countries

China

Contacts

Public ContactDongliang Mu

Peking University First Hospital

mudongliang@icloud.com+86 178 1037 0608

Outcome results

None listed

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