| 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 (Ver. 6) |
| 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 | |
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| 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 |
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| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | ASA PS 1 to 3
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| Key exclusion criteria | History of neuropsychiatric disorder
Taking psychiatric drugs Consciousness disturbance Underwent brain surgery Brain injury Underwent hepatectomy |
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| Target sample size | 30 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | Fukushima Medical University | ||||||
| Division name | Anesthesiology | ||||||
| Zip code | 9601295 | ||||||
| Address | 1 Hikarigaoka, Fukusima City, Fukushima | ||||||
| TEL | 0245471342 | ||||||
| shinjn@fmu.ac.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| Organization | Fukushima Medical University | ||||||
| Division name | Anesthesiology | ||||||
| Zip code | 9601295 | ||||||
| Address | 1 Hikarigaoka, Fukusima City, Fukushima | ||||||
| TEL | 0245471342 | ||||||
| Homepage URL | |||||||
| 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 |
| 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 |
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| 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). |
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| Results date posted |
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| Results Delayed | |||||||
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| 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. |
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| Participant flow | (Retrospective analysis) |
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| Adverse events | NA |
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| 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. |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| 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 |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014593 |