ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

NCT06344325 | Completed Phase 4

• 1 other identifier: EDPP
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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

Conditions

Elective Surgery

Outcome Measures

Primary Outcomes (1)

• Sedation score

  Sedation score (MOAA/S)

  1 day

Secondary Outcomes (1)

• Postoperative adverse reactions

  1 day

Study Arms (3)

Youth group

EXPERIMENTAL

Youth group (18-45 years old)

Drug: fospropofol

middle-aged group

EXPERIMENTAL

middle-aged group (46-65 years old)

Drug: fospropofol

elderly group

EXPERIMENTAL

elderly group (66-80 years old)

Drug: fospropofol

Interventions

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.

Also known as: fospropofol disodium

Youth group; elderly group; middle-aged group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

fospropofol

Study Officials

• aihua Du, Dr.

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 3, 2024
• Study Start: May 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)