UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009204 |
|---|---|
| Receipt number | R000010805 |
| Scientific Title | Conversion from TIVA technique to Desflurane anesthesia for long duration neurosurgery; assessment of recovery parameters |
| Date of disclosure of the study information | 2012/10/31 |
| Last modified on | 2017/08/08 17:25:22 |
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Basic information
Public title
Conversion from TIVA technique to Desflurane anesthesia for long duration neurosurgery; assessment of recovery parameters
Acronym
Conversion from TIVA technique to Desflurane anesthesia for long duration neurosurgery; assessment of recovery parameters
Scientific Title
Conversion from TIVA technique to Desflurane anesthesia for long duration neurosurgery; assessment of recovery parameters
Scientific Title:Acronym
Conversion from TIVA technique to Desflurane anesthesia for long duration neurosurgery; assessment of recovery parameters
Region
| Japan |
Condition
Condition
Neurosurgery
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The propose of this study is to evaluate the recovery parameters after conversion from TIVA technique to Desflurane anesthesia during long term neurosurgery procedures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration time to the extubation after the end of anesthetics administration
Key secondary outcomes
Duration time to the eye opening after the end of anesthetics administration.
Time to recover the orientation after the end of anesthetics administration.
Preoperative and post operative Mini-Mental State Examination scores.
Duration of intensive care unit stay.
Intraoperative monitoring parameters after the switching form propofol to desflurane.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group patients will receive propofol till the end of surgery.
Interventions/Control_2
Study group patients will be switched to desflurane from propofol.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Planned craniotomy patients.
ASA PS 1-3.
Estimated procedure time > 4 hr.
Key exclusion criteria
Malignant Hyperthermia.
History of the problem of previous anesthesia.
Contraindication for propofol and desflurane.
Preoperative cognitive disorder.
Required postoperative sedation.
Unstable vital or emergent cases.
Liver function(Child-Pugh classification of B and C) or renal function failure(CKD stage>3).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ozaki Makoto |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
Address
8-1 Kawadacho Sinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
Address
8-1 Kawadacho Sinjuku-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Baxter
Organization
Division
Category of Funding Organization
Profit organization
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 08 | Month | 08 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 08 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010805
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
