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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001293
Receipt No. R000001572
Scientific Title Relationships between electroencephalogram and plasma concentration of midazolam after induction of anesthesia
Date of disclosure of the study information 2008/12/01
Last modified on 2009/08/09

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Basic information
Public title Relationships between electroencephalogram and plasma concentration of midazolam after induction of anesthesia
Acronym Midazolam and electroencephalogram
Scientific Title Relationships between electroencephalogram and plasma concentration of midazolam after induction of anesthesia
Scientific Title:Acronym Midazolam and electroencephalogram
Region
Japan

Condition
Condition Patients undergoing operations under general anesthesia, not limited to specific diseases
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Adequate anesthetic level is required during general anesthesia. Although midazolam is used for induction of general anesthesia, there is few information regarding the relationships between plasma concentration of midazolam and electroencephalogram. We investigate the relationships between the plasma concentration of midazolam and electroencephalogram.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes plasma concentration of midazolam, bispectral index, 95% spectral edge frequency
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 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.

Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing operations of body surface or extremities under general anesthesia
Key exclusion 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Oda
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 06-6645-2186
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Oda
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 06-6645-2186
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Institution or department
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Plasma and simulated effect site concentrations of midazolam decreased rapidly and were significantly higher in the large-dose group than in the small-dose group (P = 0.005 and < 0.001, respectively). Both BIS and relative beta ratio decreased after induction and remained between 60 and 70, between -1.8 and -1.2, respectively. No differences were observed in BIS, relative beta ratio or 95% spectral edge frequency between the two groups, either. Relative beta ratio significantly correlated with BIS in both groups (r2 = 0.66 and 0.78, respectively, P < 0.001 for both). The electroencephalographic spectral power density in the beta- (&#8805;13 and <30 Hz) band was significantly increased after induction, besides being significantly larger in the large-dose group than in the small-dose group (P = 0.009).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
2008 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2009 Year 01 Month 01 Day

Other
Other related information Submitting for publication

Management information
Registered date
2008 Year 08 Month 04 Day
Last modified on
2009 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001572

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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