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Fospropofol Disodium Compared with Dexmedetomidine for Postoperative AICU Sedation in Major Abdominal Surgery: A Multicenter Randomized Trial on Efficacy, Safety, and Recovery

Fospropofol Disodium Compared with Dexmedetomidine for Postoperative AICU Sedation in Major Abdominal Surgery: A Multicenter Randomized Trial on Efficacy, Safety, and Recovery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120765
Enrollment
Unknown
Registered
2026-03-19
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Complications within 30 days after the operation

Interventions

Dexmedetomidine group:During the postoperative anesthesia recovery and mechanical ventilation in the AICU, dexmedetomidine was used for sedation.
Fospropofol disodium group:During the postoperative anesthesia recovery and mechanical ventilation in the AICU, fospropofol disodium was used for sedation.

Sponsors

The First People's Hospital of Foshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 60 years; 2. ASA classification II~III; 3. Any of the following types of tertiary or higher-level laparoscopic or open surgeries: (1). Colorectal surgery;(2). Gynecological surgery;(3). Hepatobiliary pancreatic surgery;(4). Upper gastrointestinal surgery;(5). Urological surgery/kidney surgery. 4. Duration of surgery >= 2 hours; 5. Assess Respiratory Risk in Surgical Patients in Catalonia score indicating moderate-to-high risk. (ARISCAT score >= 26 points); 6. Postoperative requirement for transfer to the AICU for recovery with endotracheal intubation and mechanical ventilation, with an anticipated duration of mechanical ventilation exceeding 1 hour.

Exclusion criteria

Exclusion criteria: 1. BMI>=35 kg/m^2; 2. Pre-existing severe infection or sepsis; 3. Recent myocardial infarction (within the past 3 months), pre-existing heart failure with reduced ejection fraction (LVEF = 40%), or severe arrhythmias necessitating vasoactive drugs for hemodynamic stability; 4. Severe renal dysfunction (Chronic Kidney Disease, CKD stage 3 or higher); 5. Severe hepatic dysfunction (Child-Pugh class C); 6. Severe central nervous system diseases (e.g., Guillain-Barré syndrome), neuromuscular diseases (e.g., myasthenia gravis), or severe psychiatric disorders (e.g., schizophrenia); 7. Known allergy or contraindication to the study drugs; 8. Pregnancy or lactation; 9. Regular use of sedative-hypnotics or psychotropic drugs for more than one week; 10. Any other condition deemed by the investigator as unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
The incidence of complications (Clavien-Dindo grade >=1) within 30 days after the operation;

Secondary

MeasureTime frame
Quality of Recovery-15 Score;The duration from the cessation of intravenous sedative drug infusion to the removal of the endotracheal tube;Total length of hospital stay;The percentage of the duration during which the target RASS score was maintained between -2 and 0, relative to the total duration of sedative drug infusion;Length of stay in the AICU;

Countries

China

Contacts

Public ContactHanbing Wang

The First People's Hospital of Foshan

whbing@fsyyy.com+86 757 8316 2519

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026