Lower Extremity SurgeryPhase 4NCT07333508
Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation
A Phase 4 study testing Fospropofol Disodium in people with Lower Extremity Surgery, run by Ya-Qun Zhou at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lower Extremity Surgery
- What is being tested?
- Fospropofol Disodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: 95% Effective Dose (ED95) of Fospropofol Disodium for Adjunctive Sedation During Spinal Anesthesia in Elderly Patients Undergoing Lower Extremity Surgery
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).
Read the detailed description
Fospropofol disodium, the only water-soluble propofol prodrug marketed in China, features mild effects on respiratory and circulatory systems, low injection pain, no lipid metabolism-related adverse reactions, and suitable duration of action-making it a promising sedative for elderly patients. However, clinical data on its use in adjuvant sedation during spinal anesthesia are lacking, with no reports on its effective dose in this specific scenario. This prospective sequential trial aims to determine the 95% effective dose (ED95) of fospropofol disodium for sedation induction and maintenance in elderly patients (≥65 years) undergoing lower extremity surgery with spinal anesthesia, providing evidence-based guidance for safe and rational clinical use.
- Conditions
- Lower Extremity Surgery
- Being tested
- Fospropofol Disodium
- Keywords
- Fospropofol Disodium, Elderly Patients, Lower Extremity Surgery, Spinal Anesthesia, Adjunctive Sedation, 95% Effective Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fospropofol DisodiumDrug
The initial induction dose is 6.0mg/kg, with a dose gradient of 0.5mg/kg (range: 4.0-8.0mg/kg). Sedation success is defined as a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤3 within 3 minutes after drug administration. Dose adjustment follows the k=3 sequential design: ① 3 consecutive successes → next patient receives a 0.5mg/kg lower dose; ② 1 failure → next patient receives a 0.5mg/kg higher dose; ③ 2 consecutive failures → skip the next gradient.
Immediately after successful induction (MOAA/S ≤3 within 3 minutes), continuous infusion of fospropofol disodium for sedation maintenance will be initiated. The initial maintenance rate is 6.0mg/kg/h, with a gradient of 0.5mg/kg/h (range: 3.0-7.5mg/kg/h). Maintenance success is defined as MOAA/S score ≤3 in ≥4 of 6 assessments (once every 10 minutes). Dose adjustment follows the k=3 sequential design: ① 3 consecutive successes → next patient receives a 0.5mg/kg/h lower rate; ② 1 failure → next patient receives a 0.
| Study group | Role | What they receive |
|---|---|---|
| Fospropofol Disodium - Sedation ED95 Exploration | Experimental | This arm aims to explore the 95% effective dose (ED95) of fospropofol disodium for sedation in elderly patients undergoing lower extremity surgery with spinal anesthesia. Receives: Drug: Fospropofol Disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
95% Effective Dose (ED95) of Fospropofol Disodium for Sedation in Elderly Patients Undergoing Lower Extremity Surgery with Spinal Anesthesia
The primary outcome is the 95% effective dose (ED95) of fospropofol disodium for adjuvant sedation during spinal anesthesia in elderly patients (≥65 years), including two key components: ① Induction ED95: The intravenous bolus dose at which 95% of patients achieve a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤3 within 3 minutes of administration (dose range: 4.0-8.0mg/kg, gradient: 0.5mg/kg); ② Maintenance ED95: The continuous intravenous infusion rate at which 95% of patients maintain an MOAA/S score ≤3 in ≥4 out of 6 intraoperative assessments (performed every 10 minutes) after successful induction (rate range: 3.0-7.5mg/kg/h, gradient: 0.5mg/kg/h). Both ED95 values (and their 95% confidence intervals [CI]) will be calculated using Probit regression analysis, with sedation success (effective=1, ineffective=0) as the dependent variable and dose/rate as the independent variable.
Measured: 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).
Secondary outcomes (6)
Induction Onset Time of Fospropofol Disodium
The time from the start of fospropofol disodium bolus injection (sedation induction phase) to the first achievement of a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤3.
Measured: From the start of fospropofol disodium bolus injection to the first achievement of MOAA/S score ≤3, assessed up to 5 minutes.
Recovery Time After Sedation Maintenance Discontinuation
The time from the cessation of fospropofol disodium continuous infusion (start of surgical skin closure) to the recovery of MOAA/S score to 5 (full alertness, rapid response to name called in normal tone).
Measured: From the moment of maintenance infusion cessation (start of surgical skin closure) to the time when MOAA/S score returns to 5, assessed up to 30 minutes.
Incidence of Respiratory Depression
The proportion of patients with respiratory depression, defined as either respiratory rate <8 breaths per minute (bpm) or oxygen saturation (SpO₂) <90% (sustained for ≥10 seconds) during the entire sedation period (induction + maintenance).
Measured: Throughout the sedation period (from induction drug injection to maintenance infusion cessation) and within 10 minutes postoperatively.
Intraoperative Changes in Mean Arterial Pressure (MAP)
Change in mean arterial pressure (MAP) relative to baseline value (recorded after lumbar anesthesia stabilization pre-sedation). Key observation points include: 1 minute, 3 minutes, 5 minutes post-induction; and at each MOAA/S assessment time point during maintenance (every 10 minutes). The maximum decrease/increase percentage of MAP from baseline is calculated (e.g., maximum MAP decrease = [(baseline MAP - intraoperative minimum MAP)/baseline MAP] × 100%).
Measured: Baseline (pre-sedation), 1/3/5 min post-induction, and every 10 minutes during maintenance.
Intraoperative Changes in Heart Rate (HR)
Change in heart rate (HR) relative to baseline value (recorded after lumbar anesthesia stabilization pre-sedation). Key observation points include: 1 minute, 3 minutes, 5 minutes post-induction; and at each MOAA/S assessment time point during maintenance (every 10 minutes). The maximum decrease/increase percentage of HR from baseline is calculated (e.g., maximum HR decrease = [(baseline HR - intraoperative minimum HR)/baseline HR] × 100%).
Measured: Baseline (pre-sedation), 1/3/5 min post-induction, and every 10 minutes during maintenance.
Incidence of Postoperative Adverse Reactions
The proportion of patients experiencing adverse reactions within 24 hours postoperatively, including:
Cardiovascular reactions: Hypertension (SBP >160 mmHg or increase of ≥30% from baseline), tachycardia (HR >100 bpm); Gastrointestinal reactions: Nausea, vomiting; Neurological/psychological reactions: Postoperative agitation (restlessness, inability to cooperate with nursing care), dizziness; Others: Injection site pain, pruritus, paresthesia (recorded if persistent for ≥24 hours postoperatively).
Measured: Within 24 hours postoperatively (assessed during ward rounds or follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ya-Qun Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ya-Qun Zhou, Tongji Hospital
- Investigators
- Ya-Qun Zhou, Principal investigator, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333508
- Sponsor's protocol ID
- LBFED95
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 95% Effective Dose (ED95) of Fospropofol Disodium for Adjunctive Sedation During Spinal Anesthesia in Elderly Patients Undergoing Lower Extremity Surgery
- ClinicalTrials.gov ID
- NCT07333508
- Acronym / sponsor ID
- LBFED95
- Conditions
- Lower Extremity Surgery
- Keywords
- Fospropofol Disodium, Elderly Patients, Lower Extremity Surgery, Spinal Anesthesia, Adjunctive Sedation, 95% Effective Dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ya-Qun ZhouUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Fospropofol disodium, the only water-soluble propofol prodrug marketed in China, features mild effects on respiratory and circulatory systems, low injection pain, no lipid metabolism-related adverse reactions, and suitable duration of action-making it a promising sedative for elderly patients. However, clinical data on its use in adjuvant sedation during spinal anesthesia are lacking, with no reports on its effective dose in this specific scenario. This prospective sequential trial aims to determine the 95% effective dose (ED95) of fospropofol disodium for sedation induction and maintenance in elderly patients (≥65 years) undergoing lower extremity surgery with spinal anesthesia, providing evidence-based guidance for safe and rational clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fospropofol Disodium - Sedation ED95 Exploration | Experimental | Drug: Fospropofol DisodiumThis arm aims to explore the 95% effective dose (ED95) of fospropofol disodium for sedation in elderly patients undergoing lower extremity surgery with spinal anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fospropofol DisodiumThe initial induction dose is 6.0mg/kg, with a dose gradient of 0.5mg/kg (range: 4.0-8.0mg/kg). Sedation success is defined as a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤3 within 3 minutes after drug administration. Dose adjustment follows the k=3 sequential design: ① 3 consecutive successes → next patient receives a 0.5mg/kg lower dose; ② 1 failure → next patient receives a 0.5mg/kg higher dose; ③ 2 consecutive failures → skip the next gradient. Immediately after successful induction (MOAA/S ≤3 within 3 minutes), continuous infusion of fospropofol disodium for sedation maintenance will be initiated. The initial maintenance rate is 6.0mg/kg/h, with a gradient of 0.5mg/kg/h (range: 3.0-7.5mg/kg/h). Maintenance success is defined as MOAA/S score ≤3 in ≥4 of 6 assessments (once every 10 minutes). Dose adjustment follows the k=3 sequential design: ① 3 consecutive successes → next patient receives a 0.5mg/kg/h lower rate; ② 1 failure → next patient receives a 0. | Drug | Fospropofol Disodium - Sedation ED95 Exploration |
Primary outcome
95% Effective Dose (ED95) of Fospropofol Disodium for Sedation in Elderly Patients Undergoing Lower Extremity Surgery with Spinal Anesthesia
Time frame: 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).
The primary outcome is the 95% effective dose (ED95) of fospropofol disodium for adjuvant sedation during spinal anesthesia in elderly patients (≥65 years), including two key components: ① Induction ED95: The intravenous bolus dose at which 95% of patients achieve a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤3 within 3 minutes of administration (dose range: 4.0-8.0mg/kg, gradient: 0.5mg/kg); ② Maintenance ED95: The continuous intravenous infusion rate at which 95% of patients maintain an MOAA/S score ≤3 in ≥4 out of 6 intraoperative assessments (performed every 10 minutes) after successful induction (rate range: 3.0-7.5mg/kg/h, gradient: 0.5mg/kg/h). Both ED95 values (and their 95% confidence intervals [CI]) will be calculated using Probit regression analysis, with sedation success (effective=1, ineffective=0) as the dependent variable and dose/rate as the independent variable.
6 secondary outcomes
Induction Onset Time of Fospropofol Disodium
Time frame: From the start of fospropofol disodium bolus injection to the first achievement of MOAA/S score ≤3, assessed up to 5 minutes.
Recovery Time After Sedation Maintenance Discontinuation
Time frame: From the moment of maintenance infusion cessation (start of surgical skin closure) to the time when MOAA/S score returns to 5, assessed up to 30 minutes.
Incidence of Respiratory Depression
Time frame: Throughout the sedation period (from induction drug injection to maintenance infusion cessation) and within 10 minutes postoperatively.
Intraoperative Changes in Mean Arterial Pressure (MAP)
Time frame: Baseline (pre-sedation), 1/3/5 min post-induction, and every 10 minutes during maintenance.
Intraoperative Changes in Heart Rate (HR)
Time frame: Baseline (pre-sedation), 1/3/5 min post-induction, and every 10 minutes during maintenance.
Incidence of Postoperative Adverse Reactions
Time frame: Within 24 hours postoperatively (assessed during ward rounds or follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ya-Qun Zhou principal investigator
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fospropofol Disodium in people with Lower Extremity Surgery, run by Ya-Qun Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ya-Qun Zhou, Dr. (+86-027-83663171, yqzhou2019@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
95% Effective Dose (ED95) of Fospropofol Disodium for Sedation in Elderly Patients Undergoing Lower Extremity Surgery with Spinal Anesthesia (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.