UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024341 |
|---|---|
| Receipt number | R000028026 |
| Scientific Title | Effect of antiemetic dose of droperidol on bispectral index during desuflurane anesthesia: making a comparison between desflurane and sevoflurane. |
| Date of disclosure of the study information | 2016/10/24 |
| Last modified on | 2016/10/08 11:54:14 |
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Basic information
Public title
Effect of antiemetic dose of droperidol on bispectral index during desuflurane anesthesia: making a comparison between desflurane and sevoflurane.
Acronym
Effect of antiemetic dose of droperidol on bispectral index during desuflurane anesthesia: making a comparison between desflurane and sevoflurane.
Scientific Title
Effect of antiemetic dose of droperidol on bispectral index during desuflurane anesthesia: making a comparison between desflurane and sevoflurane.
Scientific Title:Acronym
Effect of antiemetic dose of droperidol on bispectral index during desuflurane anesthesia: making a comparison between desflurane and sevoflurane.
Region
| Japan |
Condition
Condition
under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of antiemetic dose of droperidol on bispectral index during desflurane anesthesia and sevoflurane anesthesia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Droperidol immediately decrease the bispectral index during desflurane anesthesia and sevoflurane anesthesia.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 1mg droperidol during desflurane anesthesia.
Interventions/Control_2
Administration of 2mg droperidol during desflurane anesthesia.
Interventions/Control_3
Administration of 1mg droperidol during sevoflurane anesthesia.
Interventions/Control_4
Administration of 2mg droperidol during sevoflurane anesthesia.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 52 | years-old | <= |
Age-upper limit
| 78 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA1,2
Key exclusion criteria
ASA3,4
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Yoneda |
Organization
PL Hospital
Division name
Department of Anesthesiology
Zip code
Address
2204,Shindo,Tondabayashi,Osaka 584-8585,Japan
TEL
0721-24-3100
takashiyoneda@plhospital.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yoneda |
Organization
PL Hospital
Division name
Department of Anesthesiology
Zip code
Address
2204,Shindo,Tondabayashi,Osaka 584-8585,Japan
TEL
0721-24-3100
Homepage URL
takashiyoneda@plhospital.or.jp
Sponsor or person
Institute
Department of Anesthesiology,PL Hospital
Institute
Department
Personal name
Funding Source
Organization
No organization
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 10 | Month | 24 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 24 | 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
| 2016 | Year | 10 | Month | 08 | Day |
Last modified on
| 2016 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028026
