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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076964
Enrollment
Unknown
Registered
2023-10-25
Start date
2023-10-30
Completion date
Unknown
Last updated
2023-10-30

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: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.
propofol group:Propofol (2-4 mg/kg) was used for anesthesia induction and propofol (4-12 mg/kg/h) was used for anesthesia maintenance.

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 89 Years

Inclusion criteria

Inclusion criteria: (1) Age = 60 years old, <90 years old; (2) ASA grade I-III; (3) Patients undergoing elective major abdominal surgery (total/partial gastrectomy, hepatectomy, splenectomy, pancreaticoduodenectomy, or abdominal surgery with a duration greater than 2 hours); (4) The expected end time of the surgery is before 20:00.

Exclusion criteria

Exclusion criteria: (1) Emergency surgery; (2) High risk patients with obstructive sleep apnea (STOP-Bang questionnaire score of 3 or above); (3) Severe cardiac insufficiency (preoperative LVEF<30% or NYHA grade IV); (4) Severe liver dysfunction (Child Pugh C grade); (5) Severe renal dysfunction (receiving dialysis before surgery); (6) Transfer to intensive care unit after surgery; (7) Allergies to research drugs; (8) Preoperative inability to communicate and cooperate with research due to severe dementia or language disorders.

Design outcomes

Primary

MeasureTime frame
Total duration of sleep on the first night after surgery;

Secondary

MeasureTime frame
Sleep efficiency, number of wakefulness and fragmentation index on the first night after surgery;Total sleep duration, sleep efficiency, number of wakes and fragmentation index on the second and third nights after surgery;Subjective sleep quality score from the first night of surgery to the third night after surgery;Cognitive function score on the fifth day after surgery or on the day of discharge;Sleep quality score at 30 days after surgery;

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