UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016193 |
|---|---|
| Receipt number | R000018771 |
| Scientific Title | The effect of droperidol on Bispecral index and AEP Index under general anesthesia. |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2019/01/16 18:04:43 |
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Basic information
Public title
The effect of droperidol on Bispecral index and AEP Index under general anesthesia.
Acronym
The effect of droperidol on Bispecral index and AEP Index under general anesthesia.
Scientific Title
The effect of droperidol on Bispecral index and AEP Index under general anesthesia.
Scientific Title:Acronym
The effect of droperidol on Bispecral index and AEP Index under general anesthesia.
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia in elective surgery.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of small dose administration of droperidol on bispectral index and AEP index during or after general anesthesia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of bispectral index and AEP index after administration of droperidol.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of droperidol during general anesthesia
Interventions/Control_2
Administration of droperidol after arousal from general 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia for elective surgery and ASA physical status 1 or 2
Key exclusion criteria
Patients with neurological disorders and taking antipsychotic drugs, hearing disturbance, extrapyramidal symptoms, long QT in preoperative electrocardiogram
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikito Kawamata |
Organization
Shinshu University school of medicine
Division name
The department of anesthesiology and resuscitology
Zip code
Address
3-1-1 Asahi Matsumoto city Nagano
TEL
0262-37-2670
masui@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanobu Hirabayashi |
Organization
Shinshu University school of medicine
Division name
The department of anesthesiology and resuscitology
Zip code
Address
3-1-1 Asahi Matsumoto city Nagano
TEL
0262-37-2670
Homepage URL
hirabayashi.ajyako@gmail.com
Sponsor or person
Institute
Shinshu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
信州大学医学部付属病院(長野県)
Shinshu University Hospital(Nagano)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 20 | 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
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018771
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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