ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

Elective Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06344325
• Other study ID #: EDPP
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: mujun Chang, Dr.
• Phone: +862783663625
• Email: changmujun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Elective Surgery

Intervention

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.

Locations

Country	Name	City	State
China	Tongji hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation score	Sedation score (MOAA/S)	1 day
Secondary	Postoperative adverse reactions	Postoperative adverse reactions such as Hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness.	1 day