UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020064 |
|---|---|
| Receipt number | R000023176 |
| Scientific Title | Small droperidol dose decreases desflurane concentration needed during breast cancer surgery: randomized double-blind study |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2015/12/17 10:28:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Small droperidol dose decreases desflurane concentration needed during breast cancer surgery: randomized double-blind study
Acronym
Droperidol and desflurane in breast surgery
Scientific Title
Small droperidol dose decreases desflurane concentration needed during breast cancer surgery: randomized double-blind study
Scientific Title:Acronym
Droperidol and desflurane in breast surgery
Region
| Japan |
Condition
Condition
breast cancer surgery
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Droperidol reportedly reduces dose of propofol needed to achieve hypnosis at anesthesia induction and needed to decrease the bispectral index in propofol sedated patients during spinal anesthesia. We previously found supplemental droperidol to decrease BIS during sevoflurane with remifentanil administration. The aim of this study was to investigate droperidol's effect on desflurane consumption in daily clinical settings
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was to investigate the saving effect of DHB on the consumption of desflurane
Key secondary outcomes
The secondary endpoint included circulatory parameters, the times from the end of surgery to extubation and discharge between the groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Either droperidol0.02mg/kg or saline placebo was administrated to patients 30 minutes after induction. During anesthesia, blinded anesthesiologists in charge maintained BIS values at 50 by modulating inhaled desflurane concentrations.
Interventions/Control_2
The secondary endpoint included circulatory parameters, the times from the end of surgery to extubation and discharge between the groups.
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
| Not applicable |
Gender
Female
Key inclusion criteria
mastectomy or quadrantectomy
Key exclusion criteria
reconstructive procedures
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maiko Satomoto |
Organization
Tokyo Madical and Dental University
Division name
Anesthesiology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
TEL
+81358035325
satomoto.mane@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Satomoto |
Organization
Tokyo Madical and Dental University
Division name
Anesthesiology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
TEL
+81358035325
Homepage URL
satomoto.mane@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical Nd Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical Nd Dental University, Department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Tokyo Medical and Dental University (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 03 | 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
The average volumes of consumed desflurane were 27.2ml in the droperidol group and 41.3ml in the control group
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
| 2014 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 03 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2015 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023176
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
