Relationships between electroencephalogram and plasma concentration of midazolam after induction of anesthesia

UMIN ID: UMIN000001293

Registered date:01/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients undergoing operations under general anesthesia, not limited to specific diseases
• Date of first enrollment: 2007/10/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

After starting recoriding of electroencephalogram in the operating room, general anesthesia is induced with bolus midazolam of 0.2 mg/kg and the trachea is intubated. Blood is obtained from indwelling arterial or venous catheters 5, 10, 15, 20, 30, 45 and 60 minutes following induction of anesthesia.
After starting recoriding of electroencephalogram in the operating room, general anesthesia is induced with bolus midazolam of 0.3 mg/kg and the trachea is intubated. Blood is obtained from indwelling arterial or venous catheters 5, 10, 15, 20, 30, 45 and 60 minutes following induction of anesthesia.

Outcome(s)

• Primary Outcome: plasma concentration of midazolam, bispectral index, 95% spectral edge frequency

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) patients undergoing thoracotomy or lapalotomy, 2) patients with advanced hepatic or renal dysfunction, 3) taking cytochrome P4503A inducers or inhibitors preoperatively, 4) predicted difficulty in tracheal intubation, 5) receiving CYP3A inhibitors during anesthesia, 6) receiving medications affecting electroencephalogram

Related Information

• Primary Sponsor: Department of Anesthesiology, Osaka City University Graduate School of Medicine
• Source(s) of Monetary Support: Institution or department