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Early exploratory clinical study on the effects of anesthesia on intracranial pressure and cerebral hemodynamics in patients with skull defects.

Early exploratory clinical study on the effects of anesthesia on intracranial pressure and cerebral hemodynamics in patients with skull defects.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092065
Enrollment
Unknown
Registered
2024-11-08
Start date
2024-11-15
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

Skull defects, hemorrhagic brain diseases, malignant intracranial tumors, traumatic intracranial hematomas

Interventions

Skull Defect Group:None
Skull Integrity Group:Anesthesia drug

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 to 75 undergoing cranioplasty or decompressive craniectomy, any gender. (2) Those willing to use effective contraception during the study, and women of childbearing age must have a negative pregnancy test. (3) Signing the informed consent form and agreeing to participate in all visits, examinations, and treatments as required by the study protocol.

Exclusion criteria

Exclusion criteria: 1. Known eye pathology or history of optic nerve damage; 2.(2) Unable to access the ultrasound window; 3.(3) Clinical or radiological suspicion of cerebral venous thrombosis or vascular spasm; 4.(4) Patients with severe valvular heart disease or diagnosed with refractory atrial fibrillation; 5.(5) Patients with severe respiratory, circulatory, hepatic, or renal insufficiency who cannot tolerate treatment and examination; 6.(6) Severe febrile illness or viral disease in the past 12 weeks; 7.(7) Pregnant or lactating women; 8.(8) Participants who have participated in or are participating in this study or other clinical trials in the 12 weeks prior to enrollment; 9.(9) Other conditions deemed unsuitable for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Optic nerve sheath diameter, pulsatility index, straight sinus blood flow velocit;

Countries

China

Contacts

Public ContactMokai

Zhujiang Hospital of Southern Medical University

mokai303@163.com+86 20 6278 2860

Outcome results

None listed

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