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Comparative study on efficacy and safety of Remimazolam toluene sulfonate and dexmedetomidine in patients with severe neurologic disease

Comparative study on efficacy and safety of Remimazolam toluene sulfonate and dexmedetomidine in patients with severe neurologic disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045313
Enrollment
Unknown
Registered
2021-04-10
Start date
2021-04-15
Completion date
Unknown
Last updated
2021-11-22

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

Conditions

severe neurologic disease

Interventions

Remimazolam group:Rimazolam (load dose 0.2mg/kg, maintenance dose 0.1mg/kg/h~0.45mg/kg/h)
Dexmedetomidine group:Dexmedetomidine (loading dose 1ug/kg, maintenance dose 0.2-0.7ug /kg/h)

Sponsors

Neurosurgery of Zhangjiajie City People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Basal ganglia cerebral hemorrhage: 1.Age 18~65 years; 2.History of hypertension; 3.Spontaneous cerebral hemorrhage (except re-bleeding); 4.Location: Basal ganglia (caudate nucleus, lenticular nucleus, internal capsule, external capsule, nucleus pleura, external capsule); 5.Cerebral hemorrhage breaks into or does not break into the ventricle. Image data is ordered by neurosurgeon + imaging doctor. Aneurysmal subarachnoid hemorrhage: 1.Age 18~65 years old; 2.Spontaneous subarachnoid hemorrhage; 3.Perfect head CTA or DSA to indicate a ruptured aneurysm; 4.With or without intracerebral hematoma; 5.Cerebral hemorrhage breaks into or does not break into the ventricle. Image data is ordered by neurosurgeon + imaging doctor. Brain Injury: 1.Age 18~65 years old; 2.History of trauma; 3.Head CT suggests intracranial hemorrhage, with or without intracerebral hematoma; 4.With or without ventricular hemorrhage; 5.Surgery is clearly indicated and requires surgical treatment. Image data is ordered by neurosurgeon + imaging doctor. Suspected vascular disease or tumor stroke needs to complete related examinations.

Exclusion criteria

Exclusion criteria: Basal ganglia cerebral hemorrhage: 1.Basic diseases of liver and kidney dysfunction (on admission); 2.Severe cardiopulmonary disease (on admission); 3.History of related drug allergy; 4.Severe brain herniation who refuses surgery; 5.History of mental disorders; 6.Unexpected events during treatment need to terminate the trial. Aneurysmal subarachnoid hemorrhage: 1.Severe cardiopulmonary disease (on admission); 2.Basic diseases of liver and kidney dysfunction (on admission); 3.History of related drug allergy; 4.Surgery indications clearly refused surgery, or rebleeding condition worsened; 5.History of mental disorders; 6.Unexpected events during treatment need to terminate the trial. Brain Injury: 1.Severe cardiopulmonary disease (on admission); 2.Basic medical history of liver and kidney dysfunction (at the time of admission); 3.History of related drug allergy; 4.Surgery indications clearly refused surgery, or rebleeding condition worsened; 5.History of mental disorders; 6.Suspicious stroke with arteriovenous malformation, aneurysm or tumor; 7.Unexpected events during treatment need to terminate the trial; 8.There are obvious neurological symptoms and signs in the history of previous brain diseases; 9.Multiple injuries throughout the body accompanied by other organ dysfunction.

Design outcomes

Primary

MeasureTime frame
Time required to reach sedation depth;Single medication to achieve target sedation rate;Success rate of achieving target sedation;

Secondary

MeasureTime frame
ICP value at each time point between each group during maintenance dose;

Countries

China

Contacts

Public ContactHu Guancheng

Neurosurgery of Zhangjiajie City People's Hospital

huguancheng@yeah.net+86 13467441818

Outcome results

None listed

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