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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012466
Receipt No. R000014593
Scientific Title The effect of obesity on dexmedetomidine dosing in ICU patients - retrospective study
Date of disclosure of the study information 2013/12/03
Last modified on 2019/03/25

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Basic information
Public title The effect of obesity on dexmedetomidine dosing in ICU patients - retrospective study
Acronym Obesity and dexmedetomidine dosing
Scientific Title The effect of obesity on dexmedetomidine dosing in ICU patients - retrospective study
Scientific Title:Acronym Obesity and dexmedetomidine dosing
Region
Japan

Condition
Condition ASA Physical state 1 to 3, 18 - 80 year old patients who underwent elective surgery and received intravenous dexmedetomidine in the ICU
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To asses the effect of obesity on dexmedetomidine dosing in the ICU
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes dexmedetomidine dosing
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
80 years-old >=
Gender Male and Female
Key inclusion criteria ASA PS 1 to 3
Key exclusion criteria History of neuropsychiatric disorder
Taking psychiatric drugs
Consciousness disturbance
Underwent brain surgery
Brain injury
Underwent hepatectomy

Target sample size 30

Research contact person
Name of lead principal investigator
1st name Shinju
Middle name
Last name Obara
Organization Fukushima Medical University
Division name Anesthesiology
Zip code 9601295
Address 1 Hikarigaoka, Fukusima City, Fukushima
TEL 0245471342
Email shinjn@fmu.ac.jp

Public contact
Name of contact person
1st name Shinju
Middle name
Last name Obara
Organization Fukushima Medical University
Division name Anesthesiology
Zip code 9601295
Address 1 Hikarigaoka, Fukusima City, Fukushima
TEL 0245471342
Homepage URL
Email shinjn@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

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 03 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/fms/61/1/61_2014-19/_article
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/fms/61/1/61_2014-19/_article
Number of participants that the trial has enrolled 28
Results Fourteen obese patients and the same number of non-obese patients with similar backgrounds to the obese patients were selected from medical records. Doses of dexmedetomidine (DEX) in the first 48 h or until the end of sedation or extubation were calculated for comparison.
There were no significant differences in DEX dose indices between the groups. However, DEX requirements (mcg/h) were significantly increased with TBW (kg) (r = 0.51, P = 0.003), BMI (r = 0.49, P = 0.006) and LBM (kg) (r = 0.42, P = 0.02).
Results date posted
2019 Year 03 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Patients with American Society of Anesthesiologists physical status 1 to 3, aged 18-80 years old, had a body mass index (BMI) >= 30 kg/m2 and received DEX and FEN during mechanical ventilation after elective major surgeries between January 2011 and July 2013, were selected as an obese group. The same number of patients, whose background including age-group and sex were matched to those in the obese group and whose BMI was < 30 kg/m2, were randomly selected as a non-obese group. The exclusion criteria included patients with history of neuropsychiatric disorder, brain surgery, psychotropic drug usage, preoperative disturbance of consciousness, or hepatectomy, patients with brain injuries that were later identified, and patients with prolonged intra- or postoperative shock and did not respond to treatment.
Participant flow (Retrospective analysis)
Adverse events NA
Outcome measures Total doses of DEX and FEN between the initiation and the time point when sedation was terminated or the patients trachea was extubated within 48 h, or during the first 48 h when sedation was prolonged further, were extracted from medical records.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 12 Month 02 Day
Date of IRB
2013 Year 09 Month 10 Day
Anticipated trial start date
2013 Year 12 Month 03 Day
Last follow-up date
2015 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Record dexmedetomidine dosing during first 24 and 48 hours and until extubation.
2) Compare the dose between the obese (body mass index >= 30 kg/m2) and non-obese groups.

Management information
Registered date
2013 Year 12 Month 02 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=R000014593

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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