UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009941 |
|---|---|
| Receipt number | R000011644 |
| Scientific Title | Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2020/04/01 11:00:09 |
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Basic information
Public title
Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Acronym
Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Scientific Title
Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Scientific Title:Acronym
Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Region
| Japan |
Condition
Condition
Patients scheduled for general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to open eyes to the verbal command after general anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Induction and maintenance with sevoflurane
Interventions/Control_2
Induction with sevoflurane and maintenance with desflurane
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients, scheduled for general anesthesia, age equal to or more than 20, ASA physical status I-III
Key exclusion criteria
Patient refusal, contraindication for the drugs used in the protocol
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ikuomi |
| Middle name | |
| Last name | Mikuni |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2583
mikuni-ikuomi@kbd.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Ikuomi |
| Middle name | |
| Last name | Mikuni |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2583
Homepage URL
mikuni-ikuomi@kbd.biglobe.ne.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University
Address
2-1-1-1 Midorogaoka Higashi, Asahikawa, Hokkaido, JAPAN
Tel
0166-68-2583
mikuni-ikuomi@kbd.biglobe.ne.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
旭川医科大学病院（北海道）
釧路赤十字病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000011644
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12630-015-0514-9
Number of participants that the trial has enrolled
52
Results
Emergence and recovery were significantly faster in the desflurane group than the sevoflurane group.
Results date posted
| 2020 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were
patients aged over 20 years and American Society of
Anesthesiologists physical status I-III.
Participant flow
Patients were randomly assigned to either the sevoflurane group or the desflurane group.
Adverse events
None.
Outcome measures
The time from discontinuation of volatile anesthetics to eye opening, obeying the command to squeeze the investigator's hand, tracheal extubation, and orientation to the patients' full name, date and place.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011644
