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 UMIN000027317
Receipt No. R000031297
Scientific Title An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Date of disclosure of the study information 2017/05/12
Last modified on 2018/05/21

* 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 An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Acronym An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Scientific Title An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Scientific Title:Acronym An examination for pharmacokinetics of anesthetic drugs in patients undergoing awake craniotomy
Region
Japan

Condition
Condition Diseases on nurosurgery undergoing awake craniotomy
Classification by specialty
Anesthesiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Both scalp block and local infiltration anesthesia are very important for pain relief during awake craniotomy, and therefore we must ensure success and safety when performing these techniques. In awake craniotomy guidelines in Japan, long acting drugs such as ropivacaine and levobupivacaine are recommended. However, the relationships of a given dose with serum concentration and local anesthetic toxicity are not clear. In this study, we administrated levobupivacaine for scalp block and local infiltration anesthesia, and we evaluated the safety of local anesthesia by measuring the serum concentration of levobupivacaine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes New method got from this research is safe for awake craniotomy.
Key secondary outcomes Evaluation of serum concentration with pharmacokinetic/phamacodynamic model which was already published by calculating MDPE/MDAPE.

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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients classified as ASA-PS class I or II undergoing awake craniotomy
Key exclusion criteria Patients with anemia
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Yamakage
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 291, Minami 1 Nishi 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email yamakage@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahito Omote
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 291, Minami 1 Nishi 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email omote@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization Sapporo Medical University(Self funding)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 05 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information After induction of general anesthesia, performing a scalp block, blood samples are collected frequently, serum concentrations of anesthetic durgs are mesured by by high-performance liquid chromatography (HPLC).

Management information
Registered date
2017 Year 05 Month 12 Day
Last modified on
2018 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031297

Research Plan
Registered date File name
2017/11/30 自主臨床研究実施計画書-awakecraniotomy.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.