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Effect of fospropofol disodium for injection vs propofol in patients undergoing Total Intravenous Anesthesia,A multicenter, randomized, blind, controlled study

Effect of fospropofol disodium for injection vs propofol in patients undergoing Total Intravenous Anesthesia,A multicenter, randomized, blind, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100048
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-04-03
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None

Interventions

Experimental group (Group F):Fopropofol disodium for injection for induction and maintenance of general anesthesia
Control group (group P):propofol for induction and maintenance of general anesthesia

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.18<=age<=65 years, gender unlimited; 2. Body mass index (BMI) 18-30kg/m^2; 3. Patients who intend to undergo elective laparoscopic cholecystectomy under general anesthesia, and the estimated operation time is less than 2 hours; 4. ASA anesthesia grading I.~II; 5. No contraindication to general anesthesia; 6. Have certain understanding and communication skills, understand the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial in detail before the trial, understand the research procedures and voluntarily sign the informed consent form in writing.

Exclusion criteria

Exclusion criteria: 1.Relative contraindications of general anesthesia: patients with serious heart and lung function diseases; 2.Patients with a history of hypertension; 3.The clinician judged that the abnormal liver function was clinically significant, and the ALT and AST were > 1.5 times the upper limit of normal values; 4.Renal dysfunction, creatinine greater than the normal upper limit; 5.People with a history of mental illness or long-term psychotropic drugs (dementia, schizophrenia), a history of chronic analgesic drug use, a history of alcoholism, and cognitive impairment; 6.Any cerebrovascular accident, such as stroke or transient ischemic attack (TIA), occurred within 6 months; 7.Diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular disease, diabetic nephropathy; 8.There are patients with severe infections; 9.Allergy to the experimental drug; 10.Unable to cooperate to complete the test, the patient or family rejected the participant; 11.Pregnant or breastfeeding women or patients (including men) who plan to have a baby within 6 months;

Design outcomes

Primary

MeasureTime frame
Incidence and frequency of hypotension during anesthesia;

Secondary

MeasureTime frame
Dosage and frequency of norepinephrine;Recovery time;Induction and maintenance success rate of anesthesia;Incidence of agitation during recovery;Intraoperative awareness;Postoperative recovery quality;Postoperative pain score;Length of stay and cost;Adverse reactions during and after operation;

Countries

China

Contacts

Public ContactShibiao Chen

The first affiliated hostipal of nanchang university

chenlaoshi1111@163.com+86 791 88692556

Outcome results

None listed

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