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Clinical Study on the Efficacy and Safety of Fospropofol Disodium Injection for Induction and Maintenance of General Anesthesia

Clinical Study on the Efficacy and Safety of Fospropofol Disodium Injection for Induction and Maintenance of General Anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095331
Enrollment
Unknown
Registered
2025-01-06
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Chronic sinusitis

Interventions

Propofol group:Propofol
Fospropofol disodium group:Fospropofol Disodium Injection

Sponsors

DALIAN NO.3 PEOPLE'S HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18 to 65 years old, no gender restriction; 2.American Society of Anesthesiologists (ASA) physical status classification: I-III; 3.Body Mass Index (BMI): 18.5 to 30 kg/m²; 4.Subjects requiring elective surgery under general anesthesia with an expected duration of surgery longer than 30 minutes; 5.Voluntary participation with signed informed consent;

Exclusion criteria

Exclusion criteria: 1.Subjects with contraindications to general anesthesia or a history of anesthesia accidents; 2.Subjects with craniocerebral injury, intracranial hypertension, stroke, unstable angina pectoris, or myocardial infarction; 3.Subjects with respiratory insufficiency, obstructive lung disease, difficult airway, or assessed as difficult tracheal intubation (Modified Mallampati Class III or IV); 4.Subjects with uncontrolled diabetes or hypertension; 5.Subjects with a history of drug abuse, alcoholism, or drug dependence; 6.Subjects with abuse or long-term use of anesthetics, sedatives, or analgesics; 7.Subjects with known or suspected allergy or contraindication to any component of the study drug or to sufentanil citrate injection, propofol, remifentanil hydrochloride injection, or fospropofol disodium injection specified in the protocol; 8.Subjects with a history of mental illness; 9.Subjects who have participated in any drug clinical trial within 1 month prior to screening; 10.Pregnant and lactating women; fertile women or men unwilling to use contraception throughout the trial period; study participants (including male participants) with plans to conceive within 1 month after the trial; 11.Subjects whom the investigator considers to have any other factors that make them unsuitable for participation in this trial;

Design outcomes

Primary

MeasureTime frame
Changes in hemodynamic indices (SBP/DBP, MAP, HR, SpO2) and BIS values at various monitoring time points;;

Countries

China

Contacts

Public ContactZhao Shiling

DALIAN NO.3 PEOPLE'S HOSPITAL

13942689966@163.com+86 411 86525346

Outcome results

None listed

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