UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012863
Receipt number R000015030
Scientific Title The effect of pneumoperitoneum on perfusion index and pleth variability indicate
Date of disclosure of the study information 2014/01/15
Last modified on 2016/07/15 14:40:14

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Basic information

Public title

The effect of pneumoperitoneum on perfusion index and pleth variability indicate

Acronym

The effect of pneumoperitoneum on perfusion index and pleth variability indicate

Scientific Title

The effect of pneumoperitoneum on perfusion index and pleth variability indicate

Scientific Title:Acronym

The effect of pneumoperitoneum on perfusion index and pleth variability indicate

Region

Japan


Condition

Condition

Laparoscopic surgical procedure under general anesthesia

Classification by specialty

Gastrointestinal surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate prospectively changes in perfusion index and pleth variability indicate during pneumoperitoneum

Basic objectives2

Others

Basic objectives -Others

To investigate prospectively changes in perfusion index and pleth variability indicate during pneumoperitoneum

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in perfusion index and pleth variability indicate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Immediately before pneumoperitoneum, baseline values are recorded, and the values are recorded again for 5 minutes after pneumoperitoneum. Furthermore, immediately before the end of pneumoperitoneum, baseline values are recorded, and the values are recorded again for 5 minutes after the end of pneumoperitoneum.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with ASA physical status 1 or 2

Key exclusion criteria

1. Subjects who have an inappropriate clinical history for efficacy and safety
assessment in the study (such as drug poisoning, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood, etc)
and who is taking any drugs (including health supplements).
2. Any history for drug allergy.
3. Subjects who are inadequate for enrollment judged by the investigator.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Zen'ichiro Wajima

Organization

Shioya hospital, International University of Health and Welfare

Division name

Department of Anesthesiology

Zip code


Address

77 Tomita Yaita-shi, Tochigi, Japan

TEL

0287-44-1155

Email

zwajima@iuhw.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Zen'ichiro Wajima

Organization

International University of Health and Welfare

Division name

Department of Anesthesiology

Zip code


Address

77 Tomita Yaita-shi, Tochigi, Japan

TEL

0287-44-1155

Homepage URL


Email

zwajima@iuhw.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

None

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

2014 Year 01 Month 15 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

Completed

Date of protocol fixation

2013 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 15 Day

Last modified on

2016 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name