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The Effects of Fospropofol disodium and Propofol on Hemodynamic Changes and Postoperative Cognitive Dysfunction during General Anesthesia Induction for Laparoscopic Colorectal Cancer Surgery in the Elderly: A Randomized Controlled Study

The effect of Fospropofol disodium and Propofol on postoperative delirium in elderly patients undergoing laparoscopic surgery: A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114716
Enrollment
Unknown
Registered
2025-12-17
Start date
2025-12-19
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Postoperative Cognitive Dysfunction

Interventions

The group of Fospropofol disodium (Group F):Sufentanil 0.3 µg/kg was intravenously injected, and propofol disodium phosphate was diluted to 20 ml at a concentration of 10 mg/kg for intravenous infusio
Propofol group (Group P):Sufentanil was administered intravenously at a dose of 0.3 µg/kg, and propofol was diluted to 20 ml by a concentration of 1.5 mg/kg for intravenous infusion

Sponsors

The Affiated Cancer Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age > 65 years old, gender not limited; 2. Scheduled laparoscopic surgery (Gastrointestinal surgery, Gynecology, Urology); 3.ASA Classification II-III grades; 4. The preoperative Mini-Mental State Examination (MMSE) score is greater than or equal to 24 points; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe cardiovascular and cerebrovascular diseases (such as NYHA grade >=III or LVEF=160/100 mmHg); Has acute coronary syndrome or stroke occurred within 6 months 2. Abnormal liver and kidney functions (ALT, AST>2 times the upper limit, eGFR<60 ml/min/1.73m^2) 3. Long-term use of sedative/antidepressant drugs before the operation (more than 1 month); 4. Severe hearing impairment, visual impairment, and neuropsychiatric disorders that interfere with neuropsychological tests; 5. Allergic to propofol, disodium phosphopropofol or soybeans/eggs; 6. The operation time is less than 1 hour or more than 4 hours, and the intraoperative blood loss is greater than 15ml/kg or intraoperative blood transfusion

Design outcomes

Primary

MeasureTime frame
The occurrence of postoperative cognitive dysfunction;Serum markers: Claudin-5, S100ß;

Secondary

MeasureTime frame
Detection of serum markers;Duration of delirium, anesthesia recovery indicators (induction time, recovery time, extubation time), incidence of adverse reactions (hypertension, hypotension, injection pain, abnormal sensations, postoperative nausea and vomiting, etc.), dosage of vasoactive drugs;Electroencephalogram (EEG) monitoring indicators and non-invasive hemodynamic indicators;

Countries

China

Contacts

Public ContactLiu Jing

The Affiliated Cancer Hospital of Guizhou Medical University

lixingqiao01@163.com+86 177 8564 6483

Outcome results

None listed

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