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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039262
Receipt No. R000044777
Scientific Title Finding parameters of analgesia during surgery under general anesthesia (prospective observational study)
Date of disclosure of the study information 2020/01/27
Last modified on 2020/01/26

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Basic information
Public title Finding parameters of analgesia during surgery under general anesthesia (prospective observational study)
Acronym Finding parameters of analgesia under general anesthesia
Scientific Title Finding parameters of analgesia during surgery under general anesthesia (prospective observational study)
Scientific Title:Acronym Finding parameters of analgesia under general anesthesia
Region
Japan

Condition
Condition Adult patients undergoing elective surgery with laparotomy
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Obsterics and gynecology Urology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find parameters of analgesia during surgery under general anesthesia.
Basic objectives2 Others
Basic objectives -Others Exploratory observation of parameters which have correlation with nociception and analgesia.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Parameters, which are derived from hemodynamic monitor, that have correlation with nociception and analgesia.
Key secondary outcomes

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 Adult patients undergoing elective surgery with laparotomy
Key exclusion criteria Patients with severe arrhythmias which requires treatment
Patients with severe muscle disease which requires treatment
Patients with Alcohol or drug abuse
Patients with psychiatric disease which requires anti-psychiatric treatment
Patients with Body Mass Index (BMI) over 30
Patients with allergy to the drugs which are used perioperatively
Patients who are possible pregnant, pregnant, or breastfeeding
Patients who are considered to be difficult to participate due to psychiatric disease or symptoms
Patients who are considered to be ineligible
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kohei
Middle name
Last name Godai
Organization Kagoshima University Hospital
Division name Department of Anesthesiology
Zip code 890-8520
Address 8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL +81992755430
Email kouhei84@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Kohei
Middle name Kohei
Last name Godai
Organization Kagoshima University Hospital
Division name Department of Anesthesiology
Zip code 890-8520
Address 8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL +81992755430
Homepage URL
Email kouhei84@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization Nihon Kohden Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The ethics committee of Kagoshima University Hospital
Address 8-35-1 Sakuragaoka, Kagoshima, Kagoshima
Tel +81992756624
Email crmc@m2.kufm.kagoshima-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
2020 Year 01 Month 27 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 Open public recruiting
Date of protocol fixation
2020 Year 01 Month 24 Day
Date of IRB
2019 Year 11 Month 11 Day
Anticipated trial start date
2020 Year 01 Month 24 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: prospective cohort study
Patient selection: all eligible patients who undergo surgery when thresearchers are available during study period
Data collection: perioperative hemodynamic monitoring parameters

Management information
Registered date
2020 Year 01 Month 26 Day
Last modified on
2020 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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