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Evaluation of the Efficacy and Safety of Fospropofol Disodium for injection in General Anesthesia: A Prospective, Multi-center, Single-blind, Randomized Controlled Non-inferiority Trial.

Evaluation of the Efficacy and Safety of Fospropofol Disodium for injection in General Anesthesia: A Prospective, Multi-center, Single-blind, Randomized Controlled Non-inferiority Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093849
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-12-12
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

None

Interventions

Diprivan group:Induction and maintenance of anesthesia with Diprivan

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 to 65 years, regardless of gender, BMI = 18~30 kg/m²; (2) ASA I-III classification; (3) Patients scheduled for elective non-cardiothoracic, non-neurosurgical surgeries under general anesthesia, with an expected duration of surgery >=2 hours and requiring endotracheal intubation; (4) Able to understand the study procedures and voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) History of anesthetic complications; (2) Hepatic dysfunction (ALT or AST >= 2.5 times the upper limit of normal, TBIL >= 1.5 times the upper limit of normal); (3) Renal dysfunction (Cr > upper limit of normal, or dialysis treatment within 28 days prior to surgery); (4) Known allergy or contraindication to the investigated drug or other anesthetic agents; (5) Pregnant or breastfeeding women; (6) Any other factors deemed by the investigator to be unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
The success rate of both anesthesia induction and maintenance;

Secondary

MeasureTime frame
Duration of successful anesthesia induction;Duration of eyelash reflex disappearance;Investigating the duration proportion of BIS values maintained within the range of 40-60 from the onset to the end of drug maintenance;The time from discontinuation of anesthesia maintenance drugs to patient awakening;Extubation time;The time from discontinuation of anesthesia maintenance drugs to patient readiness for discharge (the operating room or post-anesthesia care unit);Perioperative Hemodynamic Status;Incidence and Severity of Postoperative Delirium;Adverse Reaction Occurrence;Medication Utilization;Pharmacokinetic (PK) Parameters;Incidence of Movement During Anesthesia Maintenance;Incidence of Hypotension or Hypertension During Anesthesia;Incidence of Postoperative Respiratory Depression;Incidence of Injection-Site Pain ;The Occurrence of Paresthesia;

Countries

China

Contacts

Public ContactChan Chen

West China Hospital of Sichuan University

chenchan@scu.edu.cn+86 189 8060 6260

Outcome results

None listed

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