UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016462 |
|---|---|
| Receipt number | R000019115 |
| Scientific Title | Investigation of perioperative management for awake craniotomy |
| Date of disclosure of the study information | 2015/02/06 |
| Last modified on | 2021/08/12 10:33:20 |
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Basic information
Public title
Investigation of perioperative management for awake craniotomy
Acronym
Perioperative management of awake craniotomy
Scientific Title
Investigation of perioperative management for awake craniotomy
Scientific Title:Acronym
Perioperative management of awake craniotomy
Region
| Japan |
Condition
Condition
Brain tumor
Classification by specialty
| Anesthesiology | Neurosurgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An iMRI-guided neurosurgery with functional mapping under awake craniotomy contributes the maximal surgical resection with a minimal risk of postoperative deficits when a tumor is in or adjacent to the eloquent area. However, it could be challenging because of unsecured airways with risks of vomiting, epileptic attacks or unstable levels of consciousness.
In this study, we reviewed anaesthetic charts, surgical dictations and clinical records for awake craniotomy for glioma resection to evaluate our strategy of preoperative management. Our study will contribute to improve quality of the patient management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between anesthesia method and tumor removal rate
Key secondary outcomes
1. Age
2. Gender
3. Height, Weight BMI, ASA physical status classification
4. Symptom, KPS (Karnofsky Performance Status), Perioperative anti-epileptic treatment
5. Tumor pathology, WHO Grade, Tumor location, Clinical course, Removal rate
6. Anesthesia time, Operative time, Microscopic operation time, Time of awake phase
7. Intraoperative airway management, Intraoperative ventilation, Intraoperative fluid balance
8. Intraoperative vital sign
8. Premedication, Intraoperative medication (sedative, analgesics, NMBA)
10. Intraoperative vasoactive agents
11. Intraoperative neurophysiological monitoring, Intraoperative MRI, Intraoperative photodynamic therapy
12. Intraoperative neurological complication and its management
13. Intraoperative cardiorespiratory complication and its management
14. Intraoperative complications except 12 & 13 and their management
15. Postoperative complication and its management
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Awake craniotomy cases performed at Tokyo Women's Medical University Hospital dating from November 1999 to December 2015.
Key exclusion criteria
Patients declined to participate in any studies.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozaki |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
162-8666
Address
8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
TEL
+81-3-5269-7336
mozaki@anes.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ozaki |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
162-8666
Address
8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
TEL
+81-3-5269-7336
Homepage URL
mozaki@anes.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's 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
Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
Tel
+81-3-5269-7336
hos-keiyaku.bm@twmu.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 06 | 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
358
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
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analyzed
Management information
Registered date
| 2015 | Year | 02 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019115
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/08/12 | 研究計画書4.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/08/12 | 研究計画書4.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/08/12 | データUMIN.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/19115
