Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation

NCT ID: NCT07333508

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-03-01

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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fospropofol Disodium - Sedation ED95 Exploration

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.

Group Type: EXPERIMENTAL

Fospropofol Disodium

Intervention Type: 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.

Interventions

Fospropofol Disodium

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ya-Qun Zhou

OTHER

Sponsor Role: lead

Responsible Party

Ya-Qun Zhou

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ya-Qun Zhou

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Countries

China

Central Contacts

Ya-Qun Zhou, Dr.

Role: CONTACT

yqzhou2019@hust.edu.cn

+86-027-83663171

Xi-Jian Ke, Dr.

Role: CONTACT

kexijian@hust.edu.cn

+86-027-83665431

Other Identifiers

LBFED95

Identifier Type: -

Identifier Source: org_study_id