Skip to content

A Randomized, Controlled, Single-blind, Multicenter Study on the Efficacy of Fospropofol Combined with Propofol for General Anesthesia Induction in Adult Patients Undergoing Elective Gynecological Surgery

A Randomized, Controlled, Single-blind, Multicenter Study on the Efficacy of Fospropofol Combined with Propofol for General Anesthesia Induction in Adult Patients Undergoing Elective Gynecological Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111764
Enrollment
Unknown
Registered
2025-11-05
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Induction phase of general anesthesia

Interventions

Fospropofol Group (F group):During the induction period, Group F received fospropofol 12 mg/kg.The MOAA/S score was assessed every 30 +/- 10 seconds after the initiation of fospropofol administration
Propofol Group (P group):During the induction period, Group P received propofol 2.0 mg/kg. The MOAA/S score was assessed every 30 +/- 10 seconds after the initiation of propofol administration until t
Fospropofol Combined with Propofol Group (FP group):During the induction period, Group FP first received fospropofol 6 mg/kg, followed by propofol 1.0 mg/kg after the completion of the fospropofol inj

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18–65 years; 2. American Society of Anesthesiologists (ASA) physical status: I–III; 3. Body Mass Index (BMI): 18.5–30 kg/m^2; 4. Scheduled for elective gynecological laparoscopic surgery under general anesthesia with endotracheal intubation, with an expected surgery duration of 1.5–3 hours; 5. Willing to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals with contraindications to general anesthesia or those with a history of anesthesia-related complications; 2. Acute heart failure; unstable angina; myocardial infarction within 6 months prior to screening; moderate to severe valvular heart disease; resting ECG heart rate = 2.5 × ULN, TBIL >= 1.5 × ULN; 10. Abnormal kidney function: urea or blood urea nitrogen >=1.5 × ULN, serum creatinine above the upper limit of normal; 11. History of drug abuse, substance addiction, or alcoholism within 2 years prior to the screening period. Alcoholism is defined as an average daily alcohol intake exceeding 2 units (1 unit = 360 mL beer, or 45 mL of 40% distilled spirits, or 150 mL wine); 12. Patients who have not received standard antihypertensive treatment or have poorly controlled blood pressure (sitting systolic blood pressure during screening >= 160 mmHg or = 90 mmHg); 13. Patients with hypokalemia (serum potassium 4 L/day, urine osmolality < 200 mOsm/(kg·H2O), urine specific gravity < 1.005); 14. Patients allergic to or with contraindications for fospropofol, benzodiazepines, opioids, propofol, or flurbiprofen ester, and their components; 15. Participation in any clinical trial as a subject within the past 3 months; 16. Patients who, in the investigator's opinion, are unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Induction success rate;Time to successful induction;time to loss of eyelash reflex;the incidence and severity of injection pain;the incidence and severity of paresthesia;

Secondary

MeasureTime frame
time to awakening;time to discharge;rescue medication utilization;PONV score and management;

Countries

China

Contacts

Public ContactJing Tian

Tianjin Medical University General Hospital

tianjing_tjgh@126.com+86 158 2208 3800

Outcome results

None listed

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