UMIN-CTR Clinical Trial

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

Patients receiving general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Estimating opioid sensitivity.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Anesthesiology and Critical Care, Hiroshima University Hospital

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

09

Month

16

Day

URL releasing protocol

https://www.nature.com/articles/s41598-021-87636-7

Publication of results

Unpublished

URL related to results and publications

https://www.nature.com/articles/s41598-021-87636-7

Number of participants that the trial has enrolled

30

Results

The MECK was significantly correlated (P < 0.001) with the rate of change of systolic blood pressure (ROCBP) at the time of skin incision.
Bland-Altman plot analysis using the predicted value of ROCBP calculated from the MECK and the measured value of ROCBP showed that the prediction formula for ROCBP was highly accurate.

Results date posted

2021

Year

09

Month

29

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The study population consisted of patients over 20 years of age who underwent open surgery under general anesthesia from July 2019 to October 2019.

Participant flow

Prior to the study, we received approval from the Ethics Committee of Hiroshima University. This study was conducted in accordance with the Declaration of Helsinki and STROBE statement. A total of 30 patients gave their written informed consent before the study. All procedures were conducted at the Hiroshima University Hospital. We excluded patients with irregular R-R via electrocardiogram (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. If, for a patient, the mean blood pressure remained below 50 mmHg for more than 3 min during the study time, the study protocol for that patient was discontinued.

Adverse events

none

Outcome measures

Rate of change of systolic blood pressure during skin incision (ROCBP).

Plan to share IPD

IPD sharing Plan description

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 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

Registered date

2020

Year

09

Month

16

Day

Last modified on

2021

Year

09

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047741