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The safety and efficacy of remimazolam, midazolam and propofol for perioperative sedation during percutaneous tracheostomy in critically ill neurological patients

The safety and efficacy of remimazolam, midazolam and propofol for perioperative sedation during percutaneous tracheostomy in critically ill neurological patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102111
Enrollment
Unknown
Registered
2025-05-08
Start date
2023-12-01
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

Traumatic brain injury, cerebrovascular accident and Craniocerebral tumor surgery

Interventions

Remimazolam group:The sedative drug is remimazolam tosylate at a loading dose of 0.2 mg/kg and a maintenance dose of 1.0 mg/kg/h.
Propofol group:The sedative drug is propofol at a loading dose of 0.3 mg/kg/h and a maintenance dose of 1.2 mg/kg/h.

Sponsors

Beijing tiantan hospital, capital medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The primary disease is traumatic brain injury, cerebrovascular accident, or postoperative craniocerebral tumor; 2. After joint evaluation by neurosurgeons and ICU physicians, there is a need to establish a long-term artificial airway; the relevant personnel will not participate in the treatment of the method of tracheal incision; 3. Aged 18 or above; 4. No obvious intracranial hypertension; 5. The family member signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant women; 2. Infection of the skin and soft tissue in the anterior neck; 3. History of lesion or surgery in the anterior cervical region; 4. Instability of the cervical spine, such as fractures or dislocations; 5. Severe dysfunction of the coagulation system; 6. BMI>=28kg/m^2.

Design outcomes

Primary

MeasureTime frame
The incidence of hypotension;

Countries

China

Contacts

Public ContactLi Hongliang

Beijing tiantan hospital, capital medical university

arnold_lhl@126.com+86 159 1067 8616

Outcome results

None listed

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