UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000020387 |
| Receipt No. | R000020814 |
| Scientific Title | Establishment of appropriate termination method of dexmedetomidine in pediatric patients |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2019/06/30 (Ver. 10) |
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| Basic information | ||
| Public title | Establishment of appropriate termination method of dexmedetomidine in pediatric patients | |
| Acronym | Establishment of appropriate termination method of dexmedetomidine in pediatric patients | |
| Scientific Title | Establishment of appropriate termination method of dexmedetomidine in pediatric patients | |
| Scientific Title:Acronym | Establishment of appropriate termination method of dexmedetomidine in pediatric patients | |
| Region |
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| Condition | |||||||
| Condition | All pediatric patients aged 15 years and under given dexmedetomidine in their treatment corse | ||||||
| Classification by specialty |
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| Classification by malignancy | Others | ||||||
| Genomic information | NO | ||||||
| Objectives | |
| Narrative objectives1 | To confirm efficacy of gradual weaning of dexmedetomidine as a means to prevent dexmedetomidine withdrawal syndrome |
| Basic objectives2 | Safety |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Prevalence of dexmedetomidine withdrawal syndrome within 6 hours after discontinuation of dexmedetomidine based on abnormal vital signs and sedation scores |
| Key secondary outcomes | |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Single arm |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Historical |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 1 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | Change termination process of dexmedetomidine administration from sudden termination to gradual weaning. | |
| 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 | All pediatric patients who are scheduled to receive intravenous administration of dexmedetomidine either in Intensive Care Unite (ICU), Operation Room (OR), or Ward with written consent by their guardians. | |||
| Key exclusion criteria | In case participation to the research was declined or withdrawn by guardians. | |||
| Target sample size | 60 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Toho University Omori Medical Center | ||||||
| Division name | Department of Pediatrics | ||||||
| Zip code | 143-8541 | ||||||
| Address | 6-11-1, Omori-Nishi, Ota-ku, Tokyo | ||||||
| TEL | 03-3762-4151 | ||||||
| shun.yanai.md@gmail.com | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Toho University Omori Medical Center | ||||||
| Division name | Department of Pediatrics | ||||||
| Zip code | 143-8541 | ||||||
| Address | 6-11-1, Omori-nishi, Ota-ku, Tokyo | ||||||
| TEL | 03-3762-4151 | ||||||
| Homepage URL | |||||||
| shun.yanai.md@gmail.com | |||||||
| Sponsor | |
| Institute | Toho University |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Toho 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 | Toho University Omori Medical Center |
| Address | 6-11-1, Omori-nishi, Ota-ku, Tokyo |
| Tel | 03-3762-4151 |
| shun.yanai.md@gmail.com | |
| 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 | 東邦大学医療センター大森病院 |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Unpublished |
| Result | |
| URL related to results and publications | |
| Number of participants that the trial has enrolled | |
| Results | As of December 31, 2017, 56 patients have participated in the program, whereas 46 patients have completed the research intervention. Among those participants, two cases have died of exacerbation of underlying condition before planned intervention was initiated. |
| Results date posted | |
| 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 |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| 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=R000020814 |
