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Effectiveness and safety of fospropofol disodium for sedation in patients undergoing hysteroscopic surgery: A randomized controlled trial

Effectiveness and Safety of Fospropofol Disodium for Sedation in Patients undergoing Hysteroscopic Surgery: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116883
Enrollment
Unknown
Registered
2026-01-16
Start date
2025-07-28
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

None

Interventions

A group:The induction of anesthesia will use fospropofol disodium combined with sufentanil, and fospropofol disodium will be used for maintenance.
B group:The induction of anesthesia will use fospropofol disodium combined with fentanil, and fospropofol disodium will be used for maintenance.
C group:The induction of anesthesia will use propofol combined with fentanil, and propofol will be used for maintenance.

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Female patients aged 18-65 years old; 2. American Society of Anesthesiologists (ASA) classification: grades I-III; 3.Body Mass Index (BMI): 18.5 - 30 kg/m^2; 4.The surgery will be performed under general anesthesia in the hysteroscopy; 5.Voluntary participation and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those with contraindications to general anesthesia or a history of anesthesia accidents in the past; 2.Those with brain damage, intracranial hypertension, stroke, unstable angina pectoris, or myocardial infarction; 3.Those with respiratory dysfunction, obstructive pulmonary disease, difficult airway, or judged to have difficulty with tracheal intubation (modified Mallory score level III or IV); 4.Those with uncontrolled diabetes or hypertension; 5.Those with a history of drug abuse, alcoholism, or drug dependence 6.Those who abuse or have long-term use of anesthetics, sedatives, or analgesics; 7.Those who are known or suspected to be allergic or contraindicated to any component of the study drug or to the prescribed standardized dosing procedures (fentanyl citrate injection, sufentanil citrate injection, medium/long-chain fat emulsion of propofol, sodium phospho-propane propofol for injection); 8.Those with a previous history of mental illness; 9.Those who participated in any drug clinical trial within the previous 1 month; 10.Pregnant and lactating women; women with reproductive capacity who do not wish to use contraception throughout the trial; subjects who have a pregnancy plan within 1 month after the trial; 11.Those who, in the opinion of the investigator, have any other factors that make them unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Blood pressure;Heart rate;Respiratory rate;Saturation of pulse oxygen;Incidence of adverse reactions;Dosage of vasoactive drugs;The usage amounts and addition situations of propofol and fospropofol disodium;Bispectral index;Success rate of induced sedation;

Countries

China

Contacts

Public ContactLin Yunan

The First Affiliated Hospital of Guangxi Medical University

578264804@qq.com+86 137 6827 8751

Outcome results

None listed

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