UMIN-ICDS Clinical Trial

Public title

Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery.

Acronym

Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery.

Scientific Title

Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery.

Scientific Title:Acronym

Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery.

Region

Japan

Condition

Patients scheduled for elective surgery with general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this study, patients scheduled for elective surgery with general anesthesia are the subjects. We investigate the correlation between blood pressure/pulse rate measured prior to, during and after anesthesiologists' interview, self-reported daily blood pressure/pulse rate, and blood pressure/pulse rate during anesthesia induction and surgery procedure.

Basic objectives2

Others

Basic objectives -Others

Secondarily, we also investigate the correlation between blood pressure/pulse rate variability at anesthesiologists' interview, and blood pressure/pulse rate variability during anesthesia induction/surgery procedure.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

In patients scheduled for elective surgery with general anesthesia, we investigate the correlation between blood pressure/pulse rate measured prior to, during and after anesthesiologists' interview, self-reported daily blood pressure/pulse rate, and blood pressure/pulse rate during anesthesia induction and surgery procedure. After collecting blood pressure and pulse rate data for all patients, we check the normality of the data by Shapiro-Wilk test, and multiple comparisons are performed for each item using one-way ANOVA and Bonferroni correction.

Key secondary outcomes

We investigate the correlation between the maximum variation in systolic blood pressure, diastolic blood pressure, and pulse rate measured by scheduled surgical patients before/ during/ after their anesthesiology interview before surgery and the maximum variation in systolic blood pressure, diastolic blood pressure, and pulse rate during anesthesia induction/ during surgery. After collecting data for all patients, we check the normality of the data by Shapiro-Wilk test, and multiple comparisons are performed for each item using one-way ANOVA and Bonferroni correction.

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

1)During the period from March 1, 2021 to April 30, 2022
2)Patients who received a preoperative interview by an anesthesiologist at Gunma University Hospital
3)Patients who received general anesthesia

Key exclusion criteria

1) Patients who have difficulty deciding of their own free will to participate in the research (severe dementia, mental retardation, etc.)
2) Patients under 20 years of age
3) Patients who are physically unable to have their blood pressure measured at the upper arm or wrist due to their physique or paralysis.

Target sample size

200

Name of lead principal investigator

1st name	Ikuya, Shigeru
Middle name
Last name	Koibuchi, Saito

Organization

Gunma University Hospital

Division name

Department of Anesthesiology and Intensive Care

Zip code

371-8511

Address

Gunma Prefecture, Maebashi-shi, Showa-machi, 3-39-22

TEL

027-220-8454

Email

ikoibuchi@gunma-u.ac.jp

Name of contact person

1st name	Ikuya
Middle name
Last name	Koibuchi

Organization

Gunma University Hospital

Division name

Department of Anesthesiology and Intensive Care

Zip code

371-8511

Address

Gunma Prefecture, Maebashi-shi, Showa-machi, 3-39-22

TEL

027-220-8454

Homepage URL

Email

ikoibuchi@gunma-u.ac.jp

Institute

Gunma University Hospital

Institute

Department

Personal name

Ikuya Koibuchi

Organization

Gunma University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma University Ethical Review Board for Medical Research Involving Human Subjects

Address

Gunma Prefecture, Maebashi-shi, Showa-machi, 3-39-15

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-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

群馬大学医学部附属病院（群馬県）

Date of disclosure of the study information

2023

Year

02

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

185

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

Recruitment status

No longer recruiting

Date of protocol fixation

2021

Year

12

Month

23

Day

Date of IRB

2022

Year

12

Month

27

Day

Anticipated trial start date

2022

Year

12

Month

27

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Whilst the anesthesiologist's interview at Department of Anesthesiology and Intensive Care Medicine at Gunma University Hospital,as part of routine medical care, blood pressure is measured three times; before, during, and after the interview. It is used as blood pressure reference before actual general anesthesia. First, in the outpatient clinic, we gather information of "self-reported blood pressure", a daily systolic and diastolic blood pressures measured at home or during physical examinations at work reported by the patient, and record in the patient's medical record. At the same time, the presence or absence of a blood pressure diary that records the subject's usual blood pressure is also checked. Next, during preoperative interviews and information gathering (height, weight, underlying diseases, medical history, and preoperative examination results), we measure blood pressure three times; before, during, and after the interview, and record in the patient's medical record. In this study, we will analyze the recorded blood pressure during anesthesia and surgery, focusing on the lowest blood pressure immediately before and after induction of anesthesia, the lowest blood pressure during surgery, and the highest blood pressure during surgery/anesthesia induction, and create scatter plots and perform correlation analysis. In order to compare with previous studies, we will also examine the factors that are likely to cause blood pressure fluctuations and perform multiple regression analysis.

Registered date

2023

Year

02

Month

15

Day

Last modified on

2023

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057041