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JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000945

Registered date:15/12/2007

The Intraoperative Landiolol for Intracranial Aneurysm Surgery Trials

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedTachyarrhythmia
Date of first enrollment2005/01/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeThe incidence of cardiovascular event
Secondary OutcomeHeart 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 minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1. Patients undergoing ruptured intraclanial aneurysm surgery. 2. The interval from the onset of symptoms until the operation is less than 48 hours. 3.Heart rate is 90 or more beats per minute before the operation.
Exclude criteria1.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

Contact

public contact
Name Masahiko Kawaguchi
Address 840 Shijo-cho Kashihara, Nara, Japan Japan
Telephone 0744-29-8902
E-mail drjkawa@naramed-u.ac.jp
Affiliation Nara Medical University Department of Anesthesiology
scientific contact
Name Takefumi Sakabe
Address 1-1-1 Minami-kogushi Ube, Yamaguchi Japan
Telephone 0836-22-2291
E-mail
Affiliation Yamaguchi University School of Medicine Department of Anesthesiology-Resuscitology