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New sedative dose study aims for safer surgery in seniors
NCT ID NCT07333508
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at fospropofol disodium, a sedative, to find the best dose for elderly patients (65 and older) having leg surgery with spinal anesthesia. The goal is to keep patients comfortably asleep without over-sedating them. Sixty participants will receive different doses to determine the amount that works for 95% of people.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fospropofol disodium
- What this could lead to
- If successful, this could help doctors use a safer, more precise dose of fospropofol for sedation in elderly patients during surgery.
- What could go wrong
- This is a small, early-phase trial with only 60 patients, so results may not apply to everyone. The drug may cause side effects like low blood pressure or breathing problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
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