Patients aged 18 years or older with ASA physical status 1-3 who are undergoing spinal surgery requiring a dural incision
Conditions
Interventions
None listed
Sponsors
Niigata University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 18 years or older with ASA physical status 1-3 who are scheduled to undergo spinal surgery requiring a dural incision. 2) Patients who have provided written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1)Patients with a history of hypersensitivity to any component of the administered drugs 2)Patients with acute angle-closure glaucoma 3)Patients with a history of neuromuscular disorders, including myasthenia gravis 4)Patients in shock 5)Patients with impaired consciousness 6)Patients with a history of drug dependence 7)Patients with hepatic impairment 8)Patients with a body mass index (BMI) > 35 kg/m2 or < 14 kg/m2 9)Patients under 18 years of age 10)Pregnant women 11)Patients with an ASA physical status of 4 or higher 12)Patients with cognitive impairment 13)Patients deemed ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebrospinal fluid concentration of remimazolam at the time of dural incision. | — |
Secondary
| Measure | Time frame |
|---|---|
| Predicted effect-site concentration of remimazolam at the time of dural incision. Blood concentration of remimazolam at the time of dural incision. Blood and cerebrospinal fluid concentrations of CNS7054 at the time of dural incision. Bispectral Index (BIS) value. | — |
Countries
Japan
Contacts
Public ContactYoshihiro Naito
Niigata University Graduate School of Medical and Dental Sciences Division of Anesthesiology
Outcome results
None listed