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Effect of fospropofol disodium on hemodynamics in patients undergoing supratentorial tumor resection: A randomized controlled trial

Effect of fospropofol disodium on hemodynamics in patients undergoing supratentorial tumor resection: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074155
Enrollment
Unknown
Registered
2023-07-31
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

supratentorial tumor resection

Interventions

Fopropofol group:The induction and maintenance of anesthesia were performed with fopropofol disodium.
Propofol group:The induction and maintenance of anesthesia were performed with propofol.

Sponsors

Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: If any of the following is "no", the patient cannot participate in the trial: (1) Patients undergoing supratentorial tumor resection; (2) Age 18-65 years old, gender unlimited; (3) American Society of Anesthesiologists (ASA) : Level I-III; (4) Body mass index (BMI) : 18.5~30 kg/m2; (5) Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: If any of the following is "Yes", this patient cannot participate: (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) previous history of poorly controlled hypertension or ischemic heart disease; (4) Patients with a history of intraoperative drug allergy; (5) Patients with prolonged QT interval indicated by preoperative electrocardiogram; (6) History of peripheral arterial and/or cerebrovascular diseases; (7) Patients taking anticoagulant drugs such as aspirin or with coagulation dysfunction; (8) Estimated amount of surgical bleeding > 1000ml patients; (9) Patients with preoperative cognitive dysfunction determined by MMSE scale; (10) Pregnant and lactating women; (11) Have participated in other drug trials within three months; (12) Other patients deemed unsuitable for this study by investigators;

Design outcomes

Primary

MeasureTime frame
Blood pressure;

Secondary

MeasureTime frame
Heart rate;Cardiac output;stroke volume variation;BIS value;The occurrence of intraoperative hypertension; hypotension;The occurrence of intraoperative tachycardia;The occurrence of intraoperative bradycardia;The time required for BIS to fall to 40-60 after induction of anesthesia;Intraoperative drug use;Spontaneous breathing recovery time, eye opening time, extubation time during the recovery period;Aldrete score 30 minutes after extubation;Anesthesiologist, surgeon, and patient satisfaction with the effect of anesthesia;The occurrence of perioperative adverse reactions;Postoperative cognitive function assessment;NRS pain scores after surgery;Glasgow scores after surgery;

Countries

China

Contacts

Public ContactWang E

Xiangya Hospital, Central South University

sunyao0423@163.com+86 188 7488 9950

Outcome results

None listed

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