Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059469) titled 'A Study on the Effect of the White Coat Effect on Adrenaline Induced Blood Pressure Elevation' on Oct. 21.
Study Type:
Observational
Primary Sponsor:
Institute - KANAGAWA DENTAL UNIVERSITY
Condition:
Condition - Dental Anesthesiology
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 20
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 Size - 100
Recruitment Status:
Recruitment status - Preinitiation
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068014
Disclaimer: Curated by HT Syndication.