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Synergistic Effect of Remazolam and Dexzopiclone Doses on Sleep Quality and Postoperative Delirium in Elderly Insomnia Patients

Synergistic Effect of Remazolam and Dexzopiclone Doses on Sleep Quality and Postoperative Delirium in Elderly Insomnia Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099379
Enrollment
Unknown
Registered
2025-03-21
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Primary insomnia

Interventions

Remazolam low dose group:2mg right Zopiclone was given on the night before surgery and a smart bracelet was worn. General anesthesia was induced by low dose remazolam 0.15mg/kg on the day of surgery.
Control group:No treatment was done on the night before surgery
General anesthesia was induced by propofol 2.5mg/kg on the day of operation
Remazolam medium dose group:2mg right Zopicron was given on the night before surgery and a smart bracelet was worn. General anesthesia was induced by medium dose remazolam 0.25mg/kg on the
Remazolam high dose group:On the night before surgery, 2mg dexzopicron was given and smart bracelet was worn. On the day of surgery, general anesthesia was induced by high dose remazolam 0.35mg/kg.

Sponsors

Ordos Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with delirium according to the Diagnostic and Statistical Manual of Mental Disorders (4th Edition) (DSM-IV). This included insomnia as the main issue, which comprised difficulty falling asleep, lack of deep sleep, frequent dreams, early awakenings, or problems falling asleep after waking, as well as tiredness or daytime sleepiness; 2) The primary concern was that frustration with the sleep quality leads to considerable distress or hinders social functioning; More than 3 nights/week for at least 1 month; 3) Age >= 65 years old; 4) The informed consent was signed by the patient, who willingly participated in the study.

Exclusion criteria

Exclusion criteria: 1) Recent use of medications that affect cognitive function (e.g., benzodiazepines, antidepressants/anxiety drugs, antiepileptic drugs) and a history of abuse substances; 2) Other conditions that may affect cognitive function (e.g. brain injury, stroke, mental illness, sleep apnea syndrome, chronic obstructive emphysema, hypothyroidism, hyperthyroidism, AIDS, kidney failure, Parkinson, Alzheimer, severe liver diseases, and, blood diseases); 3) The patients who withdrew, those who did not consent to be selected, and those with clear visual and auditory impairments.

Design outcomes

Primary

MeasureTime frame
S100ß;Orexin A;Cognitive function;Sleep quality;Sedation and analgesia;

Countries

China

Contacts

Public ContactShujuan Wang

Ordos Central Hospital

1451332271@qq.com+86 186 8610 5980

Outcome results

None listed

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