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The safety and efficacy of remimazolam as a potential anesthesia agent applied in certain neurosurgery cases requiring “asleep-awake-asleep” manipulation.

The safety and efficacy of remimazolam as a potential anesthesia agent applied in certain neurosurgery cases requiring "asleep-awake-asleep" manipulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111374
Enrollment
Unknown
Registered
2025-10-30
Start date
2021-06-08
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

The anesthesia of awake craniotomy

Interventions

Remimazolam tosilate group :The groups was induced and maintained under anesthesia using remimazolam besylate as the primary sedative agents.
Propofol group:The groups was induced and maintained under anesthesia using propofol as the primary sedative agents.

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 65 (including the critical values) who received awake craniotomy; 2.The patient who voluntarily participates and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe preoperative intracranial hypertension, patients presenting with cerebral herniation, or those exhibiting consciousness or cognitive impairment. 2.Preoperative communication barriers, including severe aphasia (anomic, motor, or conductive) that impedes doctor-patient communication and precludes reliable intraoperative neurological monitoring. 3.Patients with a full stomach due to failure of strict preoperative fasting, or those complicated by elevated gastric pressure, intestinal obstruction, perforation, necrosis, or other significant digestive system disorders. 4.Patients with a body mass index (BMI) >30 kg/m^2, complicated by obesity hypoventilation syndrome (OHS) or obstructive sleep apnea syndrome (OSAS). 5.Patients unable to tolerate prolonged immobilization in a fixed position, such as those with spondylitis or arthritis. 6.Patients suffering from any of the following conditions: hypertension of grade 2 or higher, New York Heart Association (NYHA) class II or higher heart disease, systemic or critical organ infection, severe hepatic or renal insufficiency. 7.Anticipated difficult airway, status post-tracheostomy, upper airway obstruction (e.g., foreign body, snoring disease), nasopharyngeal abnormalities, other severe respiratory diseases, or heavy long-term smokers. 8.Patients with other concomitant major systemic organ dysfunction or infection.

Design outcomes

Primary

MeasureTime frame
Time to awakening;Agitation score;

Countries

China

Contacts

Public ContactLlu Fuding, Peng Jun

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

670707425@qq.com+86 135 6037 1081

Outcome results

None listed

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