Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation

NCT07333508 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: LBFED95
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lower Extremity Surgery

Keywords

Fospropofol Disodium; Elderly Patients; Lower Extremity Surgery; Spinal Anesthesia; Adjunctive Sedation; 95% Effective Dose

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Throughout the sedation period (from induction drug injection to maintenance infusion cessation) and within 10 minutes postoperatively.

• Intraoperative Changes in Mean Arterial Pressure (MAP)

  Baseline (pre-sedation), 1/3/5 min post-induction, and every 10 minutes during maintenance.

• Intraoperative Changes in Heart Rate (HR)

  Baseline (pre-sedation), 1/3/5 min post-induction, and every 10 minutes during maintenance.

Study Arms (1)

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.

Drug: Fospropofol Disodium

Interventions

Fospropofol Disodium DRUG

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.

Fospropofol Disodium - Sedation ED95 Exploration

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Ya-Qun Zhou: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

fospropofol

Study Officials

• Ya-Qun Zhou

  Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Qun Zhou, Dr.

CONTACT

+86-027-83663171; yqzhou2019@hust.edu.cn

Xi-Jian Ke, Dr.

CONTACT

+86-027-83665431; kexijian@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)