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Completed

NCT Number: NCT06344325

ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tongji hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fospropofol

Drug

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

Primary outcomes

  1. Sedation score

    Time frame: 1 day

    Sedation score (MOAA/S)

Secondary outcomes

  1. Postoperative adverse reactions

    Time frame: 1 day

    Postoperative adverse reactions such as Hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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