UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005615 |
|---|---|
| Receipt number | R000006634 |
| Scientific Title | The study of physiological stress and recovery condition between AOP vs. TIVA for ambulatory general anesthesia to dental patient -Salivary alpha-amylase level and activity of autonomic nervous system were measured for mental retardation and autism patient- |
| Date of disclosure of the study information | 2011/05/17 |
| Last modified on | 2014/03/24 09:07:18 |
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Basic information
Public title
The study of physiological stress and recovery condition between AOP vs. TIVA for ambulatory general anesthesia to dental patient
-Salivary alpha-amylase level and activity of autonomic nervous system were measured for mental retardation and autism patient-
Acronym
The study of physiological stress and recovery condition for ambulatory general anesthesia
Scientific Title
The study of physiological stress and recovery condition between AOP vs. TIVA for ambulatory general anesthesia to dental patient
-Salivary alpha-amylase level and activity of autonomic nervous system were measured for mental retardation and autism patient-
Scientific Title:Acronym
The study of physiological stress and recovery condition for ambulatory general anesthesia
Region
| Japan |
Condition
Condition
dental patients with mental retardation and/or autism
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will be randomized controlled trial for physiological stress and recovery condition between AOP and TIVA for dental procedures. We measure salivary alpha-amylase and heart rate variability for stress, also measure discharge time and PONV for recovery condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
salivary alpha-amylase
discharge time
Key secondary outcomes
heart rate variability
incident of PONV
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AOP group
Patients receive sevoflurane induction. Then we stop sevoflurane after having venous line and 2mg/kg propofol, 10mg/kg/h rocuronium administer for LMA insertion. They receive 2 l/min air, 1 l/min oxygen and propofol for between BIS 40-60. Zero point one-0.2 mg/kg rocuronium administer when patients move during procedure. Two % lidocalne with adrenaline injection administer if operator need.
Data will have from May 2011 to April 2013 and end of analysis at August 2013.
Interventions/Control_2
TIVA group
Patients receive sevoflurane induction. Then we stop sevoflurane after having venous line and 2mg/kg propofol, 0.5micro g/kg/min remifentanil administer for LMA insertion. They receive either 2l/min air, 1l/min oxygen, 0.2micro g/kg/min remifentanil and propofol for between BIS 40-60. Zero point one-0.2 mg/kg rocuronium administer when patients move during procedure. Two % lidocalne with adrenaline injection administer if operator need.
Data will have from May 2011 to April 2013 and end of analysis at August 2013.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ASA class 1 or 2 mental retardation and autism patients who scheduled for dental procedure under general anesthesia.
Key exclusion criteria
Body weight under 10kg
Heart disease over NYHA class 2
Taking psychotropics
Having drug allergy
Cannot take IC of guardian
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | sunada katsuhisa |
Organization
The nippon dental university
Division name
department of dental anesthesiology
Zip code
Address
1-9-20 fujimi chiyodaku tokyo Japan
TEL
03-3261-8311
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | sunada katsuhisa |
Organization
The nippon dental university
Division name
department of dental anesthesiology
Zip code
Address
1-9-20 fujimi chiyodaku tokyo Japan
TEL
03-3261-8311
Homepage URL
katsu.sunada@nifty.com
Sponsor or person
Institute
The nippon dental university
Institute
Department
Personal name
Funding Source
Organization
The nippon dental 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
Address
Tel
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
日本歯科大学附属病院（東京都）、東京都障害者口腔保健センター（東京都）、埼玉県歯科医師会口腔保健センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 17 | 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
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
| 2011 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 17 | Day |
Last modified on
| 2014 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006634
