Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060760) titled 'Study on Salivary Secretion During Induction of General Anesthesia and Its Impact on Dental Anesthesia and Oral Surgery Conditions' on March 1.
Study Type:
Observational
Primary Sponsor:
Institute - Nagasaki university
Condition:
Condition - Patients undergoing oral and maxillofacial surgery under general anesthesia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to quantitatively evaluate changes in salivary secretion during induction of general anesthesia and to clarify their impact on airway management by dental anesthesiologists and operative conditions in oral surgery. The primary outcome is salivary flow rate during tracheal intubation (SFR2). Associations with operator subjective assessment (VAS), patient characteristics, anesthesia-related factors, and salivary properties such as surface tension will be examined in a prospective observational study. The findings are expected to contribute to safer airway management and improved surgical conditions during induction of general anesthesia.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who meet all of the following criteria will be included:
1. Patients scheduled for oral and maxillofacial surgery under general anesthesia
2. Age over 20 years
3. Written informed consent obtained after adequate explanation of the study
Key exclusion criteria - Patients meeting any of the following criteria will be excluded:
1. History of salivary gland surgery
2. History of radiation therapy to the head and neck region
3. Regular use of medications known to cause xerostomia
4. Persistent subjective symptoms of oral dryness
5. Severe hepatic or renal dysfunction
6. Patients deemed inappropriate for participation by the investigator
Target Size - 93
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 26 Day
Anticipated trial start date - 2026 Year 03 Month 01 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069525
Disclaimer: Curated by HT Syndication.