Determining the effective dose of Ciprofol for sedation during knee surgery in elderly patients
A Biased Coin Design Sequential Method for Determining the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People
This study is testing the right amount of Ciprofol to safely sedate older patients during knee surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Second Hospital of Shanxi Medical University Academic / other |
| Locations | 1 site (Taiyuan, Shanxi) |
| Trial ID | NCT06293144 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the 95% effective dose of Ciprofol for sedation in elderly patients undergoing knee arthroplasty with spinal anesthesia. Patients aged 65 and older will receive an initial loading dose of Ciprofol, followed by adjustments based on their sedation response using a biased coin design up-and-down sequential method. The study will monitor sedation levels and vital signs at multiple time points to ensure patient safety and comfort. The goal is to establish an optimal dosing regimen that minimizes adverse effects while providing effective sedation.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65 and older who are scheduled for knee arthroplasty and have an ASA grade of I to III.
Not a fit: Patients with severe psychiatric or neurological disorders, respiratory diseases, or contraindications to intrathecal anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance sedation practices for elderly patients undergoing knee surgery, improving their comfort and safety.
How similar studies have performed: While there are fewer studies specifically on Ciprofol for this population, similar approaches in sedation for elderly patients have shown promise in improving safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65 years * ASA grade I\~III * BMI 18\~28 kg/m2 Exclusion Criteria: * Contraindications to intrathecal anesthesia * Suffering from severe psychiatric or neurologic disorders or taking sedative drugs within the last 3 months * Difficult airway or having respiratory diseases such as upper airway obstruction * Severe cardiovascular system diseases * Severe hepatic or renal dysfunction * Allergy or contraindication to propofol and its drug-related components * Patient Prefusal
Where this trial is running
Taiyuan, Shanxi
- Second Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.