UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000011268
Receipt No. 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 (Ver. 20)

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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
Last 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
Email masui@fmu.ac.jp

Public contact
1st 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
Email masui@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013207