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Comprison of sedation safety and efficacy of remimazolam besylate with propofol in postoperative patients with moderate or severe craniocerebral injury

Comprison of sedation safety and efficacy of remimazolam besylate with propofol in postoperative patients with moderate or severe craniocerebral injury

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059089
Enrollment
Unknown
Registered
2022-04-24
Start date
2022-08-01
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

Neurocritical medicine

Interventions

Remimazolam besylate group:Remimazolam besylate loading dose 0.2mg kg-1,maintained at 0.1 ~ 0.45mg kg-1·h-1.
Propofol group:Propofol loading dose 2.5mg kg-1 ,maintained at 3~8mg kg-1 ·h-1.

Sponsors

First People's Hospital of Tianshui
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. There was a clear history of acute craniocerebral trauma; 2. Emergency craniocerebral CT or MRI examination confirmed craniocerebral injury; 3. GCS score <= 8; 4. Emergency craniotomy; 5. Heart rate and blood pressure were stable; 6. There were no significant organic pathological changes in heart, liver, lung, kidney and other organs; 7. There was no recent history of surgery and trauma.

Exclusion criteria

Exclusion criteria: 1. Cerebrovascular history; 2. Intracranial space-occupying lesions, ruptured intracranial aneurysms; 3. Mental disorders, cognitive impairment; 4. Patients complicated with immune diseases, patients with long-term use of hormones; 5. Patients with major trauma in other parts of the body; 6. Ophthalmic diseases such as optic nerve tumor, glaucoma, optic neuritis, severe ocular trauma, etc.

Design outcomes

Primary

MeasureTime frame
Richmond Agitation-Sedation Scale (RASS);The time of mechanical ventilation;ICU stay time;Heart Rate Variability (HRV) ;

Secondary

MeasureTime frame
Cerebral Extraction of Oxygen (CEO2);[D-(a-jv)O2];Pcv-aCO2;

Countries

China

Contacts

Public ContactLu Ming

First People's Hospital of Tianshui

iculuming@163.com+86 13609318083

Outcome results

None listed

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