Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation
China60 participantsStarted 2026-01-01
Plain-language summary
This study aims to determine the 95% effective dose (ED95) of fospropofol disodium, a new sedative drug, for adjuvant sedation during spinal anesthesia in elderly patients (aged 65 years and older) undergoing lower extremity surgery (e.g., hip/knee replacement, lower limb fracture fixation).
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥65 years, no gender restriction
* Scheduled for elective lower extremity surgery with spinal anesthesia
* ASA physical status classification Ⅰ-Ⅲ
* BMI 18.5-28.0
* Written informed consent obtained from patients or their guardians
Exclusion Criteria:
* Age \<65 years；
* Non-lower extremity surgery or conversion to general anesthesia；
* ASA physical status classification Ⅳ or above；
* BMI \<18.5 or \>28.0；
* History of drug abuse or alcohol dependence；
* Preoperative use of sedative or analgesic drugs；
* Refusal to participate or inability to sign informed consent；
* Severe arrhythmia or myocardial infarction within 3 months；
* Severe liver or kidney dysfunction；
* Severe respiratory diseases；
* Coagulopathy；
* Uncorrected severe electrolyte disturbance；
* History of mental illness or cognitive impairment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
95% Effective Dose (ED95) of Fospropofol Disodium for Sedation in Elderly Patients Undergoing Lower Extremity Surgery with Spinal Anesthesia
Timeframe: ① Induction ED95: Assessed at 3 minutes after completion of the fospropofol disodium induction bolus; ② Maintenance ED95: Assessed throughout the intraoperative maintenance phase (6 evaluations, 10 minutes apart).