The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials

UMIN ID: UMIN000000945

Registered date:15/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Tachyarrhythmia
• Date of first enrollment: 2005/01/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Landiolol hydrochloride is continuously administered during the operation. Heart rate is maintained betweeb 60 and 80bpm.
Landiolol hydrochloride is not used regardless of any heart rate. If necessary, other drugs such as diltiazem hydrochloride are allowed to use.

Outcome(s)

• Primary Outcome: The incidence of cardiovascular event
• Secondary Outcome: Heart rate Plasma cytokine Markers of tissue damage (blood nitrotyrosine, urine 80HdG, S100-beta) Incidence of delayed ischemic neuronal deficits Neurological prognosis after three months

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1.Patients with a cardiogenic shock, congestive heart failure, or hypotension (systolic blood pressure less than 90 mmHg, more than 30 minutes) 2. Patients with a diabetic ketoacidosis, or serious metabolic acidosis(BE equal or less than -10) 3. Patients with an atrioventricular block (the degree of II or III) or sick sinus syndrome. 4. Pregnant. 5. Patients with preoperative poor neurological score(Hunt and Kosnik grade 5). 6. Patients with a renal failure or undergoing hemodialysis. 7. Patients with a severe hepatic insufficiency. 8. Patients with severe obesity(body mass index equal or more than 35). 9. Patients with an immunodeficiency or medicated with the immunosuppressant. 10. Patients with an infection, such as a hepatitis B virus, a hepatitis C virus or human immunodeficiency virus, before the operation

Related Information

• Primary Sponsor: The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials Group
• Source(s) of Monetary Support: none