UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033310
Receipt No. R000035800
Official scientific title of the study Changes in cerebral oxygenation by phenylephrine or ephedrine
Date of disclosure of the study information 2018/07/06
Last modified on 2018/07/06

* 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
Official scientific title of the study Changes in cerebral oxygenation by phenylephrine or ephedrine
Title of the study (Brief title) vasopressors and cerebral oxygenation
Region
Japan

Condition
Condition Patients scheduled to have laparoscopic surgery
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the changes in cerebral oxygenation by phenylephrine or ephedrine under general anesthesia
Basic objectives2 Others
Basic objectives -Others Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in cerebral oxygenation
Key secondary outcomes Changes in cerebral hemoglobin concentration

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

Not applicable
Gender Male and Female
Key inclusion criteria 1 Patients with ASA1 or 2
2 Patients with direct arterial blood pressure monitoring
Key exclusion criteria 1 Patients with cardiovascular disease
2 Patients with cerebral disorders
3 Patients with uncontrolled DM (HbA1c>7)
Target sample size 100

Research contact person
Name of lead principal investigator Yuji Morimoto
Organization Hokkaido University Hospital
Division name Anesthesiology
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Email morim2@med.hokudai.ac.jp

Public contact
Name of contact person Yasunori Kubo
Organization Hokkaido University Hospital
Division name Anesthesiology
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email yasu-kubo@mvd.biglobe.ne.jp

Sponsor
Institute Hokkaido University Hospital
Anesthesiology
Institute
Department

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)

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 07 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 06 Day
Anticipated trial start date
2018 Year 07 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Prospective observational study

Study period:until 2019.7.5

Adult patients scheduled to have laparoscopic surgery in the Hokkaido University Hospital

Observational items: Background, laboratory data, vital signs, cerebral hemoglobin concentration and oxygenation

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035800

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.