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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041816
Receipt No. R000047741
Scientific Title Estimation of optimal dosage of opioid analgesics based on vascular stiffness
Date of disclosure of the study information 2020/09/16
Last modified on 2020/09/16

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Basic information
Public title Research on estimating the optimal dose of medical narcotics using vascular stiffness
Acronym Research on estimating the optimal dose of medical narcotics using vascular stiffness
Scientific Title Estimation of optimal dosage of opioid analgesics based on vascular stiffness
Scientific Title:Acronym Estimation of optimal dosage of opioid analgesics based on vascular stiffness
Region
Japan

Condition
Condition Patients receiving general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Estimating opioid sensitivity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Rate of blood pressure increase during skin incision
Key secondary outcomes Accuracy of the prediction formula for the rate of blood pressure increase during skin incision

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 Patients scheduled for general anaesthesia with tracheal intubation and radial arterial blood pressure measurement.
Key exclusion criteria Patients with irregular R-R on the ECG, inability to perform invasive arterial pressure measurements in the radial artery, significant hemodynamic or neurological impairment in the upper extremity, and severe stenosis or occlusive lesions in the coronary arteries or cerebral vessels.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Kamiya
Organization Hiroshima University Hospital
Division name Department of Anesthesiology and Critical Care
Zip code 734-8551
Address Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL 082-257-5555
Email d176057@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Kamiya
Organization Hiroshima University Hospital
Division name Department of Anesthesiology and Critical Care
Zip code 734-8551
Address Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL 082-257-5555
Homepage URL
Email d176057@hiroshima-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Critical Care, Hiroshima University Hospital
Institute
Department

Funding Source
Organization self funding
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 Ethics Committee of Hiroshima University
Address Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
Tel 082-257-5555
Email iryo-seisaku@office.hiroshima-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 09 Month 16 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 30
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
2019 Year 07 Month 08 Day
Date of IRB
2019 Year 07 Month 08 Day
Anticipated trial start date
2019 Year 07 Month 09 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Selection Policy for Research Subjects
(1) Selection period
End of the approval review - March 31, 2020
(2) Selection Criteria
All patients who meet the selection criteria and do not meet the exclusion criteria. Diseases are not specified.
Selection criteria
A) Patients scheduled for general anesthesia who are at least 20 years of age at the time consent is obtained and are scheduled for tracheal intubation. The planned tracheal intubation will be planned by the head of the operating room anesthesia department (different from the measurer) on the day of the planned operation, before the subject of the measurement is determined.
B) Patients are considered to have an open arterial pressure measurement with the radial artery.
The schedule for open blood arterial pressure measurement shall be planned by the chief of the anesthesiology department in the operating room on the day of the planned operation.
(different from the person being measured) before the determination of the subject of the measurement.
C) Cases in which consent has been obtained for the study.

Exclusion criteria
A) Cases with atrial fibrillation
B) Cases in which it is inappropriate to perform an ex vivo arterial pressure measurement in the radial artery.
C) Patients with significant hemodynamic or neurological impairment of the upper limb.
D) Patients with severe stenosis or obstructive lesions in the cerebral vessels.
E) Patients with contraindications to remifentanil, propofol or rocuronium.
F) Cases where prior consent was withdrawn. Other cases in which the anesthesiologist is unable to conduct this study.
Cases deemed inappropriate.

Evaluation
A) Patient background: gender, date of birth, height, weight, disease and surgical procedure.
B) Plethysmography and observational arterial pressure measurement
C) Electrocardiogram, pulse oximeter, and non-blood pressure measurement

Management information
Registered date
2020 Year 09 Month 16 Day
Last modified on
2020 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047741

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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