ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Elective Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Youth group

Youth group (18-45 years old)

Group Type EXPERIMENTAL

fospropofol

Intervention Type 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.

middle-aged group

middle-aged group (46-65 years old)

Group Type EXPERIMENTAL

fospropofol

Intervention Type 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.

elderly group

elderly group (66-80 years old)

Group Type EXPERIMENTAL

fospropofol

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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fospropofol disodium

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No