UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

dexmedetomidine dosing

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Fukushima Medical University

Institute

Department

Personal name

Organization

Fukushima Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukushima Medical University Research Ethics Committee

Address

1 Hikarigaoka, Fukushima City, Fukushima, JAPAN

Tel

0245471825

Email

rs@fmu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

12

Month

03

Day

URL releasing protocol

https://www.jstage.jst.go.jp/article/fms/61/1/61_2014-19/_article

Publication of results

Published

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

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 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.

Registered date

2013

Year

12

Month

02

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=R000014593