UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010584 |
|---|---|
| Receipt number | R000012352 |
| Scientific Title | Comparison of the quality of the awakening by the kind of the anesthetic |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2016/09/02 10:41:42 |
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Basic information
Public title
Comparison of the quality of the awakening by the kind of the anesthetic
Acronym
Comparison of the quality of the awakening by the kind of the anesthetic
Scientific Title
Comparison of the quality of the awakening by the kind of the anesthetic
Scientific Title:Acronym
Comparison of the quality of the awakening by the kind of the anesthetic
Region
| Japan |
Condition
Condition
patients scheduled for elective surgeries by general anesthesia with tracheal intubation and artificial respiration
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Anesthesiology | Plastic surgery |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the time of awakening, restoring consciousness and muscular strength
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to awakening from the anesthetic dosage end, time to recovering orientation from awakening, recovering swallowing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of 4-10mg/kg/h of propofol during general anesthesia
Interventions/Control_2
inhalation of 1-2% sevoflurane during general anesthesia
Interventions/Control_3
inhalation of 3-6% desflurane during general anesthesia
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who are American Society of Anesthesiologists Physical Status 1 or 2 and scheduled for elective operation under general anesthesia with tracheal intubation and artificial respiration
Key exclusion criteria
hypertension(bad control), hepatopathy, hepatectomy, patients that massive hemorrage is expected, renal dysfunction, patients not to awaken in the operation room, patients taking benzodiazepine continuously, alcoholic
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Niki |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-50-1, Kuramoto, Tokushima City, Tokushima, Japan
TEL
088-633-7181
norikokambe@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Niki |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-50-1, Kuramoto, Tokushima City, Tokushima, Japan
TEL
088-633-7181
Homepage URL
norikokambe@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima Graduate School, Department of Anesthesiology
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | 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
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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 24 | Day |
Last modified on
| 2016 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012352
