UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032550
Receipt number R000037092
Scientific Title Comparison of the perioperative and postoperative blood glucose change in the general anesthesia using desflurane or propofol
Date of disclosure of the study information 2018/05/11
Last modified on 2020/11/20 11:02:12

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Basic information

Public title

Comparison of the perioperative and postoperative blood glucose change in the general anesthesia using desflurane or propofol

Acronym

Comparison of the perioperative and postoperative blood glucose change in the general anesthesia using desflurane or propofol

Scientific Title

Comparison of the perioperative and postoperative blood glucose change in the general anesthesia using desflurane or propofol

Scientific Title:Acronym

Comparison of the perioperative and postoperative blood glucose change in the general anesthesia using desflurane or propofol

Region

Japan


Condition

Condition

Gynecologic case to be carried out by abdominal operation

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We use Flash glucose monitoring (FGM) where there is glucose measurement in a tissue framework and determine the effect on blood glucose change in the perioperative period by the difference of the anesthesia method.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of the glucose tolerance

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Desflurane
Until the surgery end

Interventions/Control_2

Propofol
Until the surgery end

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

ASAPS 1or2

Key exclusion criteria

hard to conduct the epidural anaesthesia

Diagnosis of diabetes

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hasegawa Makoto

Organization

Toho University Omori Medical Center

Division name

Anesthesiology

Zip code


Address

6-11-1 Omori Nishi, Ota-ku, Tokyo

TEL

03-3762-4151

Email

makoto.01.hasegawa@med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hasegawa Makoto

Organization

Toho University Omori Medical Center

Division name

Anesthesiology

Zip code


Address

6-11-1 Omori Nishi, Ota-ku, Tokyo

TEL

03-3762-4151

Homepage URL


Email

makoto.01.hasegawa@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University Omori Medical Center

Institute

Department

Personal name



Funding Source

Organization

Toho University Omori Medical Center

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


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

2018 Year 05 Month 11 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

2018 Year 05 Month 22 Day

Date of IRB

2018 Year 05 Month 22 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2020 Year 05 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 11 Day

Last modified on

2020 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037092


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name