UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001293 |
|---|---|
| Receipt number | 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 21:19:39 |
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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
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
Sponsor or person
Institute
Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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- (≥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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001572
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| Registered date | File name |
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