Relationships between patient's physiological variables and drugs in the perioperative period

UMIN ID: UMIN000047469

Registered date:15/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neurosurgery patients
• Date of first enrollment: 2022/04/18
• Target sample size: 14
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Induction and maintenance of anesthesia are performed using propofol.
Induction and maintenance of anesthesia are performed using remimazolam.

Outcome(s)

• Primary Outcome: Amplitudes in operative SEP Non-inferiority margin in amplitude set based on values of 50% reduction of the control drug.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Ina Central Hospital
• Source(s) of Monetary Support: N/A