UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039262 |
|---|---|
| Receipt number | 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 | 2023/11/11 11:00:31 |
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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 |
| Obstetrics 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
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
kouhei84@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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
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
No longer 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
| 2023 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044777
