UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011268 |
|---|---|
| Receipt number | R000013207 |
| Scientific Title | Target-controlled infusion of dexmedetomidine during surgery |
| Date of disclosure of the study information | 2013/07/25 |
| Last modified on | 2019/03/25 09:27:57 |
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Basic information
Public title
Target-controlled infusion of dexmedetomidine during surgery
Acronym
Target-controlled infusion of dexmedetomidine
Scientific Title
Target-controlled infusion of dexmedetomidine during surgery
Scientific Title:Acronym
Target-controlled infusion of dexmedetomidine
Region
| Japan |
Condition
Condition
Surgical patients who undergo dexmedetomidine sedation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the quality of sedation provided by different sedation protocols between the Target-controlled infusion TCI) and the manual infusions from the drug information.
To perform pharmacokinetic analyses in selected patients
To perform an external validation of existing pharmacokinetic models of dexmedetomidine
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequencies of respiratory and circulatory depression which require interventions
Time to loss of responsiveness after starting infusions of dexmedetomidine and time to recovery after end of infusions
Key secondary outcomes
Blood concentrations of dexmedetomidine during target controlled infusions and the recommended regimen by drug manufacturer
External evaluation of existing pharmacokinetic models using above dataset
Pharmacokinetic analysis using above data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Target-controlled infusions of dexmedetomidine during anesthesia
Interventions/Control_2
Manual infusions of dexmedetomidine according to the drug information during 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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elective surgical patients who undergo dexmedetomidine sedations with ASA criteria 1, 2 or 3.
Key exclusion criteria
1)Known allergy to dexmedetomidine
2)Histories of psychoneurotic disorders
3)Psychiatric pharmacotherapy
4)Deaf
5)Sleep apnea
6)Women who are pregnant or breast-feeding
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Murakawa |
Organization
Fukushima Medical University, School of Medicine
Division name
Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
0245471342
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Shinju |
| Middle name | |
| Last name | Obara |
Organization
Fukushima Medical University, School of Medicine
Division name
Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
0245471342
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Fukushima Medical University Research Ethics Committee
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
Tel
0245471825
rs@fmu.ac.jp
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
Fukushima Medical University Hospital, Fukushima, JAPAN
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
In patients under spinal anesthesia, the clinical outcomes of dexmedetomidine in the TCI group were not significantly different compared with that in the recommended regimen group.
In 16 patients, dexmedetomidine concentrations were measured to investigated predictive performances of published pharmacokinetic models. The model reported by Hannivoort performed the best.
(MDPE 5.6%, MDAPE 18.1%, and wobble 6.2%).
Results date posted
| 2019 | Year | 03 | Month | 25 | Day |
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
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013207
