Fospropofol Disodium for Maintenance of General Anesthesia in Elderly Patients Undergoing Laparoscopic Gastrointestinal Surgery: A Multicenter, Randomized Controlled Clinical Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500101903

Enrollment

Unknown

Registered

2025-05-05

Start date

2025-05-05

Completion date

Unknown

Last updated

2025-05-12

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

Conditions

Gastrointestinal tumors

Interventions

Fospropofol Disodium Group:For anesthesia maintenance, fospropofol disodium was administered as a continuous intravenous infusion starting at 6 mg/kg/h, with subsequent titration in 1-2 mg/kg/h increm

Propofol Group:For maintenance of anesthesia, propofol was administered as a continuous intravenous infusion starting at 2 mg/kg/h, with subsequent titration in 1-2 mg/kg/h increments to maintain Bisp

Eligibility

Sex/Gender

All

Age

65 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years, regardless of gender; 2. ASA physical status classification I-IV; 3. Scheduled for elective laparoscopic gastrointestinal surgery with an anticipated duration >1 hour; 4. Voluntarily participated and provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to fospropofol disodium or propofol; 2. BMI >30 kg/m^2 or 2× upper limit of normal); 11. Preoperative systolic blood pressure <90 mmHg; 12. Severe coagulation disorders, endocrine diseases, or other conditions compromising hemodynamic stability; 13. Current participation in other clinical trials.

Design outcomes

Primary

Measure	Time frame
The success rate of general anesthesia maintenance;	—

Secondary

Measure	Time frame
Systolic blood pressure (SBP) variability during anesthesia maintenance;Incidence of hypotension during general anesthesia maintenance;Area under the curve (AUC) of SBP below baseline values;Incidence of SBP <90 mmHg within the first hour of maintenance;Vasoactive drug usage rate, total dosage, and dose per unit time;Absolute blood pressure at key timepoints: pre-induction, post-intubation, skin incision, pneumoperitoneum establishment, end of surgery, immediately after extubation;BIS maintenance rate (40-60) from skin incision to surgery completion (%);Time to full awakening (from surgery end until MOAA/S=5 in three consecutive assessments);PACU stay duration;Adverse Events: pruritus and paresthesia, postoperative nausea and vomiting (PONV), dizziness;Total administered doses of fospropofol disodium, propofol, and remifentanil;	—

Measure

Time frame

Systolic blood pressure (SBP) variability during anesthesia maintenance;Incidence of hypotension during general anesthesia maintenance;Area under the curve (AUC) of SBP below baseline values;Incidence of SBP <90 mmHg within the first hour of maintenance;Vasoactive drug usage rate, total dosage, and dose per unit time;Absolute blood pressure at key timepoints: pre-induction, post-intubation, skin incision, pneumoperitoneum establishment, end of surgery, immediately after extubation;BIS maintenance rate (40-60) from skin incision to surgery completion (%);Time to full awakening (from surgery end until MOAA/S=5 in three consecutive assessments);PACU stay duration;Adverse Events: pruritus and paresthesia, postoperative nausea and vomiting (PONV), dizziness;Total administered doses of fospropofol disodium, propofol, and remifentanil;

—

Countries

China

Contacts

Public ContactYongquan Chen

Wannan Medical College Yijishan Hospital

chenyq263@163.com+86 139 5619 6920

Outcome results

None listed

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