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Comparison of the Efficacy and Safety of Fospropofol Disodium versus Propofol in Hysteroscopic Surgery: A Prospective, Randomized Controlled, Non-Inferiority Trial

Comparison of the Efficacy and Safety of Fospropofol Disodium versus Propofol in Hysteroscopic Surgery: A Prospective, Randomized Controlled, Non-Inferiority Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112272
Enrollment
Unknown
Registered
2025-11-12
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

None

Interventions

Control group:The initial dose is 2mg/kg until the revised vigilance and sedation score (MOAA/S) is less than or equal to 1 point. If the BIS is higher than 60, the supplementary dose is 0.5mg/kg
Experimental group:The initial dose is 10mg/kg until the revised vigilance and sedation score (MOAA/S) is less than or equal to 1 point. If the BIS is higher than 60, the supplementary dose is 2mg/kg

Sponsors

Zhongshan Hospital,Fudan University(Xiamen Branch)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients who are scheduled to undergo hysteroscopy or surgery; 2. American Medical Association (ASA) classification I to III; 3. Age: 18 -65 years old 4. The hysteroscopic operation time is less than 1 hour (h). 5. Body Mass Index (BMI) <30kg/m ².

Exclusion criteria

Exclusion criteria: 1. Abnormal liver and kidney functions: total bilirubin >3 times the upper limit or alanine aminotransferase and aspartate aminotransferase >5 times the upper limit ?, elevated serum creatinine >=3 times the baseline value; 2. Sinus bradycardia (HR<50bpm), atrioventricular block; 3. Preoperative hypotension (systolic blood pressure <90mmHg); 4. Preoperative hypoxia (SpO2<90%); 5. There was cognitive dysfunction before the operation; 6. Mental and psychological disorders; 7. Alcohol and drug abuse; 8. Drug allergies involved in this experiment; 9. The patient himself/herself refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
Body movement incidence rate;

Secondary

MeasureTime frame
Adverse reaction incidence rate;

Countries

China

Contacts

Public ContactPeiling Cai

Zhongshan Hospital,Fudan University(Xiamen Branch)

cai.peiling@zsxmhospital.com+86 189 3244 6938

Outcome results

None listed

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