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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024341
Receipt No. 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

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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
Email 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
Email takashiyoneda@plhospital.or.jp

Sponsor
Institute Department of Anesthesiology,PL Hospital
Institute
Department

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
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
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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028026

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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