UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059469 |
|---|---|
| Receipt number | R000068014 |
| Scientific Title | A Cohort Study on the Effect of the White Coat Effect on Adrenaline-Induced Blood Pressure Elevation |
| Date of disclosure of the study information | 2025/10/21 |
| Last modified on | 2025/10/21 12:21:24 |
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Basic information
Public title
A Study on the Effect of the White Coat Effect on Adrenaline Induced Blood Pressure Elevation
Acronym
A Study on the Effects of the White Coat Effect on Adrenergic Blood Pressure Elevation
Scientific Title
A Cohort Study on the Effect of the White Coat Effect on Adrenaline-Induced Blood Pressure Elevation
Scientific Title:Acronym
A Study on the Effects of the White Coat Effect on Adrenergic Blood Pressure Elevation
Region
| Japan |
Condition
Condition
Dental Anesthesiology
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to quantitatively compare and evaluate the effect of the white coat effect on the blood pressure increase caused by epinephrine-added local anesthetics, thereby verifying the safety of epinephrine-added local anesthetics in patients with the white coat effect.
Basic objectives2
Others
Basic objectives -Others
By quantitatively comparing blood pressure reactivity in patients exhibiting the white coat effect a distinct blood pressure pattern with that of healthy individuals, we contribute to elucidating the pathophysiological mechanisms underlying the white coat effect.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure and pulse rate after local anesthesia: Measure and record blood pressure and pulse rate twice each immediately before, immediately after, 5 minutes after, 10 minutes after, and 30 minutes after the local anesthetic injection. Compare the change rate in systolic blood pressure between the white coat effect group and the control group. Furthermore, the primary endpoint was a multivariate linear regression analysis adjusted for age, sex, BMI, medical history, epinephrine dose, and treatment content.
Key secondary outcomes
Secondary endpoints include the change rate in diastolic blood pressure, change rate in mean arterial pressure, change rate in heart rate, and incidence rate of adverse events.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing dental treatment requiring local anesthesia
Key exclusion criteria
Severe cardiovascular disease (unstable angina, myocardial infarction within the past 6 months, severe heart failure (NYHA class III/IV), severe arrhythmia)
Blood pressure-related disorders (secondary hypertension, severe hypertension )
Drug-related (Contraindications to epinephrine-containing lidocaine hydrochloride preparations, use of beta-blockers)
Pharmacologically assisted behavioral modification (Psychotropic sedation, general anesthesia)
Other (Pregnancy or lactation, contraindications to upper arm blood pressure measurement, difficulty cooperating due to dementia, psychiatric disorders, intellectual disability, etc. Deemed inappropriate by the principal investigator)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kuroda |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology, Division of Dental Anesthesiology
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
0468228751
kuroda@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kuroda |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology, Division of Dental Anesthesiology
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
TEL
0468228751
Homepage URL
kuroda@kdu.ac.jp
Sponsor or person
Institute
KANAGAWA DENTAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KANAGAWA DENTAL UNIVERSITY INSTITUTIONAL REVIEW BOARD
Address
82 Inaoka-cho, Yokosuka City, Kanagawa Prefecture
Tel
0468228751
kenkyo@kdu.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
| 2025 | Year | 10 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to quantitatively compare and evaluate the effect of the white coat effect on blood pressure elevation caused by epinephrine containing local anesthetics, and to verify the safety of epinephrine containing local anesthetics in patients with the white coat effect. Patients undergoing dental procedures requiring local anesthesia (tooth extraction, implant placement, periodontal surgery, anesthetic pulpectomy, etc.) were classified into two groups: the white coat effect group and the control group. The change in systolic blood pressure was compared between the white coat effect group and the control group using an unpaired t test and then performed multivariate linear regression analysis adjusting for age, sex, BMI, medical history, epinephrine dose, and treatment type. This was the primary endpoint. Secondary endpoints included diastolic blood pressure change rate, mean arterial pressure change rate, heart rate change rate, and adverse event incidence. This study contributes to elucidating the pathophysiological mechanisms of the white coat effect by quantitatively comparing blood pressure reactivity in patients exhibiting this specific blood pressure dynamic with that in healthy individuals.
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068014
