Neurosurgery patients
Conditions
Interventions
Induction and maintenance of anesthesia are performed using propofol.
Induction and maintenance of anesthesia are performed using remimazolam.
Sponsors
Ina Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients who are scheduled to undergo neurosurgery at Ina Central Hospital.
Exclusion criteria
Exclusion criteria: Cases in which consent was not obtained Severe cardiac disease Severe lung disease Severe liver dysfunction Severe renal dysfunction Severe metabolism disorders Obese cases with a BMI of 30 or higher Cases in which securing the airway is difficult Others that the investigators consider to be inappropriate for a participant of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amplitudes in operative SEP Non-inferiority margin in amplitude set based on values of 50% reduction of the control drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison and assessment of bioequivalence in perioperative clinical data (hemodynamics, electrophysiological intraoperative monitoring, clinical information, and so on) Assessments of non-inferiority Amplitudes and latencies in evoked potentials. Estimation with confidence intervals Non-inferiority margin in amplitude and latency set based on values of 50% reduction and 10% delay of the control drug. Detailed analysis for hemodynamic variables Factorial analysis for interactions of hemodynamics Analysis for electrophysiological intraoperative monitoring BP, HR, SEP, MEP, ABR, VEP, BIS, and so on. | — |
Countries
Japan
Contacts
Public ContactTohru Shiratori
Ina Central Hospital Medical department
Outcome results
None listed