UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039855 |
|---|---|
| Receipt number | R000045264 |
| Scientific Title | The study of the effects of intellectual disability and oral antiepileptic drugs on emergence from total intravenous anesthesia |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2024/09/19 09:57:17 |
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Basic information
Public title
The study of the effects of intellectual disability and oral antiepileptic drugs on awaking from general anesthesia
Acronym
The effects of intellectual disability and antiepileptic drugs on awaking from general anesthesia
Scientific Title
The study of the effects of intellectual disability and oral antiepileptic drugs on emergence from total intravenous anesthesia
Scientific Title:Acronym
The effects of intellectual disability and antiepileptic drugs on emergence from total intravenous anesthesia
Region
| Japan |
Condition
Condition
Dental patients undergoing total intravenous anesthesia
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of intellectual disability and antiepileptic drugs on emergence from total intravenous anesthesia with propofol by comparison of propofol pharmacokinetics, in healthy subject, intellectually disabled patients without oral antiepileptic drugs and intellectually disabled patients with oral antiepileptic drugs.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Blood concentration of propofol at the discontinuation of propofol and tracheal extubation, 2)Time from the discontinuation of propofol to tracheal extubation and 3)BIS value at tracheal extubation
Key secondary outcomes
1)Propofol amount and average infusion rate of propofol, 2)Estimated blood concentration of propofol at the discontinuation of propofol and tracheal extubation, 3)Remifentanil amount and average infusion rate of remifentanil, 4)BIS values before & during anesthesia, and at the discontinuation of propofol.
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)BMI is less than 30, 2)ASA is PS 1 or 2, 3)Anesthesia time will be less than 5 hours, 4)Patients undergoing dental treatment or minor oral surgery, 5)No need receiving opioid analgesics for postoperative analgesia
Key exclusion criteria
1)Patients with contraindications for propofol, remifentanil, rocuronium, 2)Patients who are judged to be inappropriate for study participation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Okayama University Hospital
Division name
Department of Dental Anesthesiology
Zip code
700-8525
Address
2-5-1 Shikata-cho Kita-ku Okayama
TEL
086-235-6721
higuti@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Okayama University Hospital
Division name
Department of Dental Anesthesiology
Zip code
700-8525
Address
2-5-1 Shikata-cho Kita-ku Okayama
TEL
086-235-6721
Homepage URL
higuti@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho Kita-ku Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | Day |
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
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The analysis is progressing, but we need more time for it.
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
Suspended
Date of protocol fixation
| 2020 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2024 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045264
