UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016462
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mozaki@anes.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.