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

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 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

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

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