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Phase III clinical trial of Fospropofol Disodium for Injection: a multicenter, central randomized, parallel, positive control, double-blind double simulation study

Phase III clinical trial of Fospropofol Disodium for Injection: a multicenter, central randomized, parallel, positive control, double-blind double simulation study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016410
Enrollment
Unknown
Registered
2018-05-31
Start date
2017-04-19
Completion date
Unknown
Last updated
2018-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy person

Interventions

group2:Administration: single intravenous injection
administration time: 60 s. Dosage: 2 mg/kg.

Sponsors

West China Hospital , Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) The subjects voluntarily signed the informed consent form of the trial; 2) Aged between 18~65 years, BMI 18 to 30, half males and half females; 3) ASA I, II; 4) Selective operation under general anesthesiawhich is non cardiothoracic surgery, non neurosurgery and non hepatologicaland duration=30 min and blood loss =1000 ml, and surgical subjects need tracheal intubation; 5) Laboratory and imaging findings are in normal range or abnormal but not clinical significance.

Exclusion criteria

Exclusion criteria: 1) People who have drug allergy history, allergic disease, allergic constitution; who have allergy history of narcotic drugs or drugs whos structure be similar to trial drugwho are suspected hereditary history of malignant hyperthermia; who are allergic to eggs, soybeans and their products; who have contraindications of study related drugs; 2) Pregnant, lactating women, or those who have pregnancy plans within 1 months (including male subjects); 3) Systolic pressure140 mmHg; Heart rate120 bpm; Postural hypotension subjects; 4) According to the Fridericia formula, the QT/QTc interval was significantly prolonged (male=470 ms, female =480 ms); 5) People with known or expected difficulty airway; 6) Cognitive dysfunction; 7) Coagulation disorders; 8) People who take any other drugs within two weeks before the beginning of the trial,;smoking, drinking and caffeinated beverages during the test period; 9) People who are suspected or confirmed history of alcohol or substance abuse; 10) People who participated in the drug trial (including the trial drug) within 3 months before the trialor who were repeatedly enrolled in this trial; 11) A sponsor or researcher who directly participates in the trial,or their family members; 12) People who are refused by researchers with any reason.

Design outcomes

Primary

MeasureTime frame
MOAA/S;central nervous system;circulatory system;respiratory system;liver function;renal function;

Secondary

MeasureTime frame
eyelash reflexes;BIS;recovery time;laboratory inspection;temperature;

Countries

China

Contacts

Public ContactZhaomeng Wu

West China Hospital, Sichuan University

bugmeng@163.com+86 18980601401

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026