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Efficacy and safety of fospropofol disodium in induction and maintenance of general anesthesia in elderly patients undergoing laparoscopic surgery

Efficacy and safety of fospropofol disodium in induction and maintenance of general anesthesia in elderly patients undergoing laparoscopic surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091984
Enrollment
Unknown
Registered
2024-11-07
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

The elderly patients underwent laparoscopic general anesthesia

Interventions

Experimental group:Fospropofol disodium is used for induction and maintenance of general anesthesia
Control group:Propofol is used for induction and maintenance of general anesthesia

Sponsors

Shanxi Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Age 65-85 years old, gender unlimited (2) American Society of Anesthesiologists (ASA) : Level I-III; (3) Body mass index (BMI) : 18.5~30 kg/m^2; (4) Subjects undergoing laparoscopic colorectal cancer resection under elective general anesthesia; (5) Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Chronic users of analgesics, psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants), and alcohol abusers; (2) Patients with serious heart, brain, lung, liver, kidney and other important organ dysfunction and electrolyte abnormalities before surgery; (3) Patients with previously poorly controlled hypertension or diabetes; (4) Patients with an allergic history of intraoperative drug use, allergies to eggs, soybeans and their products, and lipid metabolism disorders; (5) Patients with prolonged QT interval indicated by preoperative electrocardiogram; (5) History of peripheral arterial and/or severe cerebrovascular diseases; (6) Patients with coagulation dysfunction; (7) Patients with expected surgical bleeding volume >1000ml; (8) Patients with preoperative cognitive dysfunction determined by MMSE scale; (9) Have participated in other drug trials within three months; (10) Patients deemed unsuitable for this study by other investigators;

Design outcomes

Primary

MeasureTime frame
Sedation/anesthesia success rate: (percentage of successful induction and maintenance of anesthesia);

Secondary

MeasureTime frame
Duration of successful induction of anesthesia;Vital signs related indicators;Incidence and severity of cognitive dysfunction 1 and 3 days after surgery;Sleep quality scores at night 1 and 3 after surgery;Restlessness score (RS), Ramsay sedation score, VAS score;Incidence of adverse reactions;Inflammatory index: IL-6, TNF-a, IL-10, oxygen free radical index SOD, MDA content changes;Immune indicators: Changes in CD3+, CD4+, CD4+/CD8+;

Countries

China

Contacts

Public ContactTing Wang

Shanxi Provincial People's Hospital

108996495@qq.com+86 150 3442 1983

Outcome results

None listed

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