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To investigate the effect of oral midazolam solution on postoperative delirium in elderly orthopedic patients with sleep disorders

To investigate the effect of oral midazolam solution on postoperative delirium in elderly orthopedic patients with sleep disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118785
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-02-12
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Postoperative Delirium

Interventions

Treatment group:Take 0.08mg/kg midazolam oral solution before going to bed the night before the operation
Control group:A volume (ml) = body weight (kg) × 0.04 10% glucose solution was taken at bedtime the night before surgery

Sponsors

Third Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients undergoing elective hip or knee replacement or revision under general anesthesia; 2. Preoperative Athens Insomnia Scale (AIS) score =6; 3. Age 60-75 years old, ASA physical status I-III; 4. Elderly patients who could cooperate to complete the scale; 5. Consent to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. were participating in or had participated in other clinical trials in the past three months; 2. Patients underwent more than one operation or emergency operation during this hospitalization due to their condition; 3. body mass index (BMI) > 35 kg/m^2; 4. severe preoperative cognitive impairment, such as Alzheimer's disease or Montreal Cognitive Assessment (MoCA) score < 10. 5. Preoperative delirium or confusion assessment (CAM) was positive; 6. having a history of psychosis or taking antipsychotics, sleep-improving drugs or benzodiazepines; 7. severe respiratory and circulatory diseases such as sleep apnea syndrome; 8. severe liver and kidney damage; 9. Other conditions considered by the attending physician or investigator to be inappropriate for the study.

Design outcomes

Primary

MeasureTime frame
Delirium in the postanesthesia care unit;Postoperative Delirium;

Secondary

MeasureTime frame
Sleep quality and score;Anxiety score on the day of surgery;Perioperative vital signs;Extubation time and postanesthesia care unit stay time;Pain score;

Countries

China

Contacts

Public ContactWen Ouyang

Third Xiangya Hospital, Central South University

ouyangwen133@vip.sina.com+86 139 7493 4441

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026