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Comparison of the effects of fospropofol disodium, propofol and etomidate on hemodynamics during general anesthesia induction in patients undergoing emergency intracerebral hemorrhage surgery

Comparison of the effects of fospropofol disodium, propofol and etomidate on hemodynamics during general anesthesia induction in patients undergoing emergency intracerebral hemorrhage surgery: a single-center randomized double-blind controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107062
Enrollment
Unknown
Registered
2025-08-03
Start date
2025-08-03
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

The diagnosis conforms to the diagnostic criteria for cerebral hemorrhage in Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019, which is defined as acute onset with neurological deficit symptoms, and the presence of hemorrhage foci shown by cranial CT or MRI

Interventions

Fospropofol Disodium Group:Fospropofol Disodium Group: After entering the operating room, the patient first receives sedation with remimazolam at a dose of 0.05 mg/kg, followed by other anesthetic ind
Propofol Group:Propofol Group: After entering the operating room, the patient first receives sedation with remimazolam at a dose of 0.05 mg/kg, followed by other anesthetic induction drugs: sufentanil

Sponsors

Hainan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18–65 years, regardless of gender; (2) Emergency admission, with diagnosis conforming to the diagnostic criteria for intracerebral hemorrhage (ICH) in Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019 [17], i.e., acute onset, presence of neurological deficit symptoms, and hemorrhage foci shown by cranial CT or MRI; (3) Requiring emergency surgery under general anesthesia; (4) No tracheal intubation and mechanical ventilation performed before entering the operating room; (5) American Society of Anesthesiologists (ASA) physical status: Class I–IIIE; (6) If the patient is conscious and can accurately understand the study, he/she must voluntarily participate and sign the informed consent form; if the patient is unconscious, his/her immediate family members or authorized representatives must fully understand the study, sign the informed consent form, and agree to the patient's participation in the study.

Exclusion criteria

Exclusion criteria: (1) Patients requiring immediate rescue upon entering the operating room (such as cardiopulmonary resuscitation) or in extremely critical condition (ASA physical status >= Class IV or MEWS score >= 9); (2) Patients with definite full stomach, difficult airway, or those assessed as having difficult tracheal intubation; (3) Patients undergoing organ transplantation, cardiac surgery, or obstetric surgery; (4) Patients with a history of dependence on sedative or analgesic drugs, or a history of alcoholism or drug abuse; (5) Female patients who are pregnant, lactating, or have plans to become pregnant within 1 month of the perioperative period; (6) Patients with known or suspected allergies or contraindications to any components of the study drugs or the standardized medications specified in the protocol (fospropofol disodium for injection, propofol medium/long-chain fat emulsion, etomidate injection, remimazolam besylate for injection, sufentanil citrate injection, cisatracurium besilate for injection, remifentanil hydrochloride for injection); (7) Patients who participated in other clinical trials within 30 days before being enrolled in this study; (8) Patients for whom postoperative blood tests were not performed in the ward within 48 hours after surgery; (9) Patients who cannot cooperate or are unwilling to cooperate with the study for any reason; (10) Any other circumstances deemed inappropriate for participation in the study by the researchers.

Design outcomes

Primary

MeasureTime frame
Incidence of post-induction hypotension;

Secondary

MeasureTime frame
Hemodynamic parameters at different time points;Blood test results;Drug dosage: Intraoperative usage of vasoactive drugs;Recovery quality scores;Other adverse reactions occurring during the anesthesia emergence period;Awakening time;duration of the patient's ICU stay;total length of hospital stay;

Countries

China

Contacts

Public ContactGao Wei

Hainan Provincial People's Hospital

gaowei20055@126.com+86 138 3617 2191

Outcome results

None listed

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