ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages

Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia

Study Overview

• Status: Completed
• Conditions: Elective Surgery
• Intervention / Treatment: Drug: fospropofol

Detailed Description

As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18-80 years old, elective surgery under general anesthesia.
• ASA I-II;
• Surgical duration>30 minutes;
• Sign an informed consent form.

Exclusion Criteria:

• American Society of Anesthesiologists(ASA)≥ III;
• Body mass index (BMI)<18 kg/m2 or>30 kg/m2;
• Individuals with a history or potential history of drug abuse or alcohol dependence;
• Preoperative use of sedative or analgesic drugs;
• Individuals with severe liver and kidney dysfunction;
• Individuals who are allergic or potentially allergic to propofol and lipids;
• The types of surgeries that directly affect hemodynamics, such as large vessel surgery and other surgical procedures;
• Patients with abnormal coagulation function, endocrine disorders, or other factors affecting hemodynamic status;
• Participants in other clinical studies within the past 3 months;
• researchers deemed it inappropriate for participants to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Youth group; Youth group (18-45 years old)	Drug: fospropofol; The initial dose of fospropofol disodium in the youth group is 15mg/kg,the middle-aged group is 10mg/kg, the elderly group is 7.5mg/kg, and the concentration of adjacent intervals is 0.5mg/kg.; Other Names: fospropofol disodium
Experimental: middle-aged group; middle-aged group (46-65 years old)	Drug: fospropofol; The initial dose of fospropofol disodium in the youth group is 15mg/kg,the middle-aged group is 10mg/kg, the elderly group is 7.5mg/kg, and the concentration of adjacent intervals is 0.5mg/kg.; Other Names: fospropofol disodium
Experimental: elderly group; elderly group (66-80 years old)	Drug: fospropofol; The initial dose of fospropofol disodium in the youth group is 15mg/kg,the middle-aged group is 10mg/kg, the elderly group is 7.5mg/kg, and the concentration of adjacent intervals is 0.5mg/kg.; Other Names: fospropofol disodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation score	Sedation score (MOAA/S)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative adverse reactions	Postoperative adverse reactions such as Hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness.	1 day

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: aihua Du, Dr., Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol; Fospropofol
• Other Study ID Numbers: EDPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No