UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015701
Receipt number R000018250
Scientific Title Evaluation of serum concentration of local anesthetics after infiltration in scalp and effects of lipid emulsion infusion against local anesthetic intoxication.
Date of disclosure of the study information 2014/11/17
Last modified on 2022/05/24 05:01:58

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Basic information

Public title

Evaluation of serum concentration of local anesthetics after infiltration in scalp and effects of lipid emulsion infusion against local anesthetic intoxication.

Acronym

Evaluation of serum concentration of local anesthetics after infiltration in scalp

Scientific Title

Evaluation of serum concentration of local anesthetics after infiltration in scalp and effects of lipid emulsion infusion against local anesthetic intoxication.

Scientific Title:Acronym

Evaluation of serum concentration of local anesthetics after infiltration in scalp

Region

Japan


Condition

Condition

The patients who received brain surgery with craniotomy

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary aim of this study is evaluating serum concentration of local anesthetics after scalp infiltration to determine safe dose of local anesthetics.

Basic objectives2

Others

Basic objectives -Others

The secondary aim of this study is evaluating the effect of lipid emulsion infusion for awaking delay after craniotomy with local anesthetic infiltration.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes of serum concentration of local anesthetics

Key secondary outcomes

Lipid emulsion infusion facilitates awake from anestetic status in the patient with craniotomy


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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients who will undergo craniotomy surgery

Key exclusion criteria

The patients of their relatives do not accept Informed consent.
The patients whose ASA physical status more than 4.
The patients who are younger than 20 yo or elder than 80 yo.
The patients whose body weight is less than 40 kg.
The patients who has allergy or contraindication to the drug which may use in this study.
The patients who have renal or hepatic failure.
The patient who is received opioid preoperatively.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshinori
Middle name
Last name Kamiya

Organization

Niigata Universitu Medical and Dental Hospital

Division name

Anesthesiology

Zip code

951-8520

Address

1-754 Asahimachidori Chuo-ku, Niigata City, Japan

TEL

025-227-2328

Email

y-kamiya@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Yoshinori
Middle name
Last name Kamiya

Organization

Niigata Universitu Medical and Dental Hospital

Division name

Anesthesiology

Zip code

951-8520

Address

1-754 Asahimachidori Chuo-ku, Niigata City, Japan

TEL

025-227-2328

Homepage URL


Email

y-kamiya@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Niigata Universitu Medical and Dental Hospital

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

Niigata University Central Review Board of Clinical Research

Address

1-757 Asahimachidori Chuo-ku, Niigata City, Japan

Tel

025-368-9343

Email

crbcr@adm.niigata-u.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

2014 Year 11 Month 17 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

Terminated

Date of protocol fixation

2014 Year 11 Month 07 Day

Date of IRB

2014 Year 09 Month 20 Day

Anticipated trial start date

2014 Year 11 Month 12 Day

Last follow-up date

2022 Year 05 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Intervention study


Management information

Registered date

2014 Year 11 Month 16 Day

Last modified on

2022 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018250


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name