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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000017779 |
Receipt No. | R000020595 |
Scientific Title | Required propofol dose and time to emerge for anesthesia; affect by number of used antiepileptics and type of used antiepileptics |
Date of disclosure of the study information | 2015/06/02 |
Last modified on | 2015/06/09 |
Basic information | ||
Public title | Required propofol dose and time to emerge for anesthesia; affect by number of used antiepileptics and type of used antiepileptics | |
Acronym | Required propofol dose and time to emerge for anesthesia | |
Scientific Title | Required propofol dose and time to emerge for anesthesia; affect by number of used antiepileptics and type of used antiepileptics | |
Scientific Title:Acronym | Required propofol dose and time to emerge for anesthesia | |
Region |
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Condition | ||
Condition | patients with neurological disorder who were treated under intravenous general anesthesia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The objective of the present study was to investigate the relationship between number of used antiepileptics and the propofol dose required for anesthesia and the time to emerge from anesthesia during dental treatment in patients with neurological disorders. We also investigated these parameters in relation to type of antiepileptics. |
Basic objectives2 | Pharmacokinetics |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | anesthesia finish |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | patients with neurological disorder who were treated under intravenous general anesthesia at the Dentistry outpatient section for patients with neurological disorder, Kagoshima University Medical Dental Hospital | |||
Key exclusion criteria | The cases that did not use TCI and BIS or did not consent of study were excluded. | |||
Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kagoshima University Graduate School of Medical and Dental Sciences | ||||||
Division name | Anesthesia center | ||||||
Zip code | |||||||
Address | 8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN | ||||||
TEL | 099-275-5111 | ||||||
ken2006anes@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kagoshima University | ||||||
Division name | Anesthesia center | ||||||
Zip code | |||||||
Address | 8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN | ||||||
TEL | 099-275-5111 | ||||||
Homepage URL | |||||||
ken2006anes@yahoo.co.jp |
Sponsor | |
Institute | Department of Dental Anesthesiology, Field of Oral and Maxillofacial Rehabilitation, Kagoshima University Graduate School of Medical and Dental Sciences |
Institute | |
Department |
Funding Source | |
Organization | Kagoshima University Graduate School of Medical and Dental Sciences |
Organization | |
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IRB Contact (For public release) | |
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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 | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date analysis concluded |
Other | |
Other related information | propofol dose required for anesthesia, time to emergence, and modelled propofol blood concentration at emergence were evaluated. |
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=R000020595 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |