Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fospropofol Disodium.
- Who it may be relevant to
- Registry conditions: Lower Extremity Surgery. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
95% Effective Dose (ED95) of Fospropofol Disodium for Adjunctive Sedation During Spinal Anesthesia in Elderly Patients Undergoing Lower Extremity Surgery
Overview
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.
Interventions
- Drug 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 su
Primary outcome measures
- 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).]
Secondary outcome measures (6)
- 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).]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07333508 · LBFED95