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Application and effect of besylate remimazolam for interventional surgery in patients with intracranial aneurysms

Application and effect of besylate remimazolam for interventional surgery in patients with intracranial aneurysms

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041808
Enrollment
Unknown
Registered
2021-01-06
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

Cerebral aneurysms

Interventions

Part I (Single arm design): Remimazolam Group:The dose of besylate remimazolam was adjusted up and down according to the changes of MAP and HR.
Part II (RCT design): Group R and Group P:Group R: Remimazolam induction dose-0.3mg/kg, maintenance dose-2mg/kg/h, at the end of surgery remimazolam dose was adjusted to ED95 dose obtained from part

Sponsors

Shanxi Bethune hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. According to the history, clinical manifestations and imaging examination, the patients with intracranial aneurysms were definitely diagnosed; 2. Patients who are going to be treated with interventional embolization of intracranial aneurysms; 3. Patients aged from 18 to 65 years old; 4. Patients with anesthesia grade I ~ II of American Society of anesthesiologists (ASA).

Exclusion criteria

Exclusion criteria: 1. Patients with predicted difficult airway (cervical spondylosis, Mallampati grade III / IV, mouth opening less than 3 fingers, body mass index > 30kg / m2, etc.); 2. Patients with severe cardiopulmonary insufficiency and coagulation dysfunction; 3. Patients with chronic bronchitis, asthma, history of upper respiratory tract infection or other respiratory diseases in recent one month; 4. Patients who were converted to intracranial aneurysm clipping during operation; 5. Patients with neuropsychiatric disorders who can not cooperate; 6. Patients with previous allergy to embolic and contrast agents.

Design outcomes

Primary

MeasureTime frame
blood pressure;heart rate;Incidence of cerebral vasospasm;

Secondary

MeasureTime frame
bucking score;quality of recovery score;Incidence of hypotension;NIH Stroke Scale;levels of MMP-9;levels of NSE;levels of S100ß;

Countries

China

Contacts

Public ContactHan Chongfang

Shanxi Bethune Hospital

hanchongfang2003@foxmail.com+86 13994292958

Outcome results

None listed

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