ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

Phase 4

Recruiting

• Conditions: Elective Surgery
• Interventions: Drug: fospropofol

• Registration Number: NCT06344325
• Lead Sponsor: Tongji Hospital

Brief 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

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 Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-03
• Study Start: 2024-05-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-29
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Youth group	fospropofol	Youth group (18-45 years old)
middle-aged group	fospropofol	middle-aged group (46-65 years old)
elderly group	fospropofol	elderly group (66-80 years old)

Primary Outcome Measures

Name	Time	Method
Sedation score	1 day	Sedation score (MOAA/S)

Secondary Outcome Measures

Name	Time	Method
Postoperative adverse reactions	1 day	Postoperative adverse reactions such as Hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness.

Trial Locations

Locations (1)

Tongji hospital; 🇨🇳 Wuhan, Hubei, China