Remimazolam during cardiopulmonary bypass

JRCT ID: jRCT1011230015

Registered date:05/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cardiocascular surgery
• Date of first enrollment: 05/07/2023
• Target sample size: 36
• Study type: Interventional
• Intervention(s): Administration of remimazolam at different concentrations during cardiopulmonary bypass

Outcome(s)

• Primary Outcome: Concentration of free remimazolam

Secondary Outcome

Concentration of total remimazolam, protein binding ratio of remimazolam, concentration of a metabolite of remimazolam (CNS7054), concentration of albumin, blood gas analysis, hemodynamics, BIS value, body temperature, time of blood sampling
patients characteristics, surgery type, duration of anesthesia, duration of aortic clamp, duration of cardiopulmonary bypass, amount of fluid, dose of vasoactive agents, dose of anesthetics, amount of blood products, bleeding, urine output

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who receive cardiovascular surgery under cardiopulmonary bypass with mild hypothermia

Exclude criteria

Refusal to participate
Emergent case
Allergy against remimazolam
Acute angle closure glaucoma
Myasthenia gravis
Hepatic failure (Child Pugh equal to or more than 2)
Renal failure (sCre equal to or more than 2 mg/dL)
Obesity (BMI equal to or more than 35 kg/m2)
Deep hypothermic circulatory arrest
Patients who are considered to be inappropriate to participate to the study

Related Information

• Primary Sponsor: Yoshikawa Yusuke