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Melatonin Circadian Rhythms and Anti-inflammatory Pathways: A Clinical and Mechanistic Study on Ciprofol's Improvement of Postoperative Sleep Quality in Elderly Patients

Melatonin Circadian Rhythms and Anti-inflammatory Pathways: A Clinical and Mechanistic Study on Ciprofol's Improvement of Postoperative Sleep Quality in Elderly Patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121959
Enrollment
Unknown
Registered
2026-04-07
Start date
2026-04-07
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

(Postoperative Sleep Disturbance, POSD)

Interventions

Experimental Group (Ciprofol Group, Group C):Induction: Intravenous injection of ciprofol 0.4 - 0.5 mg/kg. Maintenance: Continuous infusion of ciprofol at 0.8 - 3.0 mg/(kg·h).
Control Group (Propofol Group, Group P):Induction: Intravenous injection of propofol 1.5 - 2.5 mg/kg. Maintenance: Continuous infusion of propofol at 4.0 - 12.0 mg/(kg·h).

Sponsors

Baiyun Hospital Affiliated to Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age: 65 - 85 years 2. Gender: No restriction 3. Physique: Body Mass Index (BMI) 18 - 30 kg/m² 4. Physical Status Classification: American Society of Anesthesiologists (ASA) Grade II - III 5. Surgical Requirements: Expected surgery duration >=2 hours. Anticipated postoperative hospital stay for observation >=3 days. 6. Informed Consent: The patient and/or legal guardian must provide signed informed consent. The patient must be able to cooperate with wearing the sleep monitoring device and completing scale assessments.

Exclusion criteria

Exclusion criteria: 1. Pre-existing Sleep Disorders: History of diagnosed severe sleep disorders (e.g., severe insomnia, untreated severe Obstructive Sleep Apnea (OSA)). 2. Medication Interference: Long-term use of sedative-hypnotics (e.g., benzodiazepines), antidepressants, or corticosteroids within 3 months prior to surgery. 3. Neuropsychiatric History: History of stroke, Alzheimer's disease, Parkinson's disease, or schizophrenia. 4. Specific Habits: History of transmeridian travel (within the past week) or long-term night shift work (indicative of circadian rhythm disruption). 5. Severe Comorbidities: Severe hepatic or renal insufficiency (Child-Pugh Class C or creatinine clearance <30 ml/min). 6. Allergies/Contraindications: Known allergy to soybean oil, eggs, dairy products, or any component of propofol/ciprofol.

Design outcomes

Primary

MeasureTime frame
(Sleep Efficiency, SE);

Secondary

MeasureTime frame
Sleep Architecture Parameters;Circadian Rhythm and Molecular Mechanism Metrics;Clinical Prognostic Indicators;

Countries

China

Contacts

Public ContactLiu Jiming

Baiyun Hospital Affiliated to Guizhou Medical University

sunly310@163.com+86 189 8430 8266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026