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A multicenter, single blind, randomized controlled clinical trial on the efficacy and safety of intravenous injection of fospropofol disodium for general anesthesia maintenance in children undergoing elective surgery

A multicenter, single blind, randomized controlled clinical trial on the efficacy and safety of intravenous injection of fospropofol disodium for general anesthesia maintenance in children undergoing elective surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125816
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

None

Interventions

Fospropofol disodium Group:Anesthesia maintenance using fospropofol disodium
Propfol Group:Anesthesia maintenance using propel

Sponsors

Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Aged 3 to 12 years, of either gender, with a BMI of 18 to 30 kg/m^2; 2. ASA physical status I to II; 3. Requiring elective surgery under general anesthesia, with an estimated operation time of >=60 minutes, and requiring tracheal intubation/laryngeal mask airway, without involving controlled hypotension or other surgeries that may significantly affect the circulatory system; (including but not limited to: urethroplasty in urology, tethered cord release in neurosurgery, selective rhizotomy, arthroscopic exploration and repair in orthopedics, etc.); 4. Family members who can understand the content of this study, are willing to participate, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients who have previously experienced anesthesia accidents; 2. Patients with abnormal liver function (ALT or AST = 2.5 times the upper limit of normal, TBIL = 1.5 times the upper limit of normal); 3.Patients with abnormal renal function (Cr > upper limit of normal, or undergoing dialysis treatment within 28 days before surgery); 4.Patients with abnormal blood lipids (TC > 170mg/dL; TG > 75mg/dL for ages 3-9, TG > 90mg/dL for ages 10-12); 5.Patients who are allergic to or have contraindications to the trial drug or other anesthetic drugs; 6. Patients who, in the investigator's opinion, have any other factors that make them unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
BIS;drug dose;

Secondary

MeasureTime frame
HR;Blood pressure;recovery time;additional drug dose;rate of adverse event;

Countries

China

Contacts

Public ContactSiyi Zhou

Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai

shirley_zsy@126.com+86 136 1196 1010

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026