Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation

Starting soon · Phase 4

Conditions studied: Lower Extremity Surgery

In brief

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).

Key facts

Study ID

NCT07333508

Run by

Ya-Qun Zhou

People needed

60

Starts

2026-01-01

Expected to finish

2027-03-01

Last updated by the study team

2026-01-13

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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