Development of pharmacokinetic simulator for adrenaline infusion

JRCT ID: jRCT1031230653

Registered date:27/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Left ventricular dysfunction, Aortic/Mitral valve stenosis, Aortic/Mitral valve regurgitation
• Date of first enrollment: 27/02/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Blood specimen collection before and during general anesthesia

Outcome(s)

• Primary Outcome: serum adrenaline concentration
• Secondary Outcome: hypotensive events

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: < 91age old
• Gender: Both

Include criteria

(1) Moderate or severe aortic/mitral valve regurgitation
(2) Moderate or severe aortic/mitral valve stenosis
(3) Left ventricular ejection fraction <=50%

Exclude criteria

Disease, condition, and physical status that affect adrenaline metabolism.
(1) Off pump CABG
(2) Arrhythmia requiring care
(3) Patients who are administered with catecholamine
(4) Patients under mechanical ventilation
(5) Unruptured cerebral aneurysm of surgical indication
(6) Allergy or contradiction for investigative drugs
(7) Dialysis patients
(8) Hepatic dysfunction (Child-Pugh grade C)
(9) One lung ventilation
(10) Height<150 cm
(11) BMI>=30 kg/m2
(12) Patients administered with anti-psychotic or -depressant drug
(13) Patients administered with monoamine oxidase inhibitor
(14) Patients administered with steroids
(15) Hyperthyroidism
(16) Patients considered inappropriate for trial

Related Information

• Primary Sponsor: Sasaki Makoto
• Source(s) of Monetary Support: Special Target Research Fund