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

Not Applicable

Recruiting

• Conditions: eurosurgery patients

• Registration Number: JPRN-UMIN000047469
• Lead Sponsor: Ina Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-15
• Last Update Posted: 17 October 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amplitudes in operative SEP Non-inferiority margin in amplitude set based on values of 50% reduction of the control drug.

Secondary Outcome Measures

Name	Time	Method
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.