UMIN-CTR Clinical Trial

Public title

Study on Salivary Secretion During Induction of General Anesthesia and Its Impact on Dental Anesthesia and Oral Surgery Conditions

Acronym

Salivary Secretion in Oral Surgery

Scientific Title

Clinical Significance of Salivary Secretion Changes During Induction of General Anesthesia: A Prospective Observational Study in Dental Anesthesia and Oral Surgery Settings

Scientific Title:Acronym

Dental Anesthesia and Salivary Secretion in Oral Surgery

Region

Japan

Condition

Patients undergoing oral and maxillofacial surgery under general anesthesia

Classification by specialty

Anesthesiology	Oral surgery	Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome is the salivary flow rate during tracheal intubation under induction of general anesthesia.
Salivary flow rate will be calculated by measuring the weight of saliva collected through routine oral and pharyngeal suction during anesthesia induction and dividing it by the collection time to obtain secretion volume per unit time.

Key secondary outcomes

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 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 sample size

93

Name of lead principal investigator

1st name	Shota
Middle name
Last name	Tsukimoto

Organization

Nagasaki university hospital

Division name

Department of Dental Anesthesiology

Zip code

852-8501

Address

1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan

TEL

095-819-7714

Email

shtsukimoto@gmail.com

Name of contact person

1st name	Shota
Middle name
Last name	Tsukimoto

Organization

Nagasaki University Hospital

Division name

Department of dental anesthesiology

Zip code

852-8501

Address

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken

TEL

095-821-7714

Homepage URL

Email

s-tsukimoto@nagasaki-u.ac.jp

Institute

Nagasaki university

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

Nagasaki University Hospital Clinical Research Ethics Committee

Address

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-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

2026

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

02

Month

26

Day

Date of IRB

Anticipated trial start date

2026

Year

03

Month

01

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a non-interventional observational study. General anesthesia and oral surgery procedures will be performed as part of routine clinical care without modification for research purposes. Saliva samples obtained through routine oral and pharyngeal suction during anesthesia induction will be used for research analysis. Surface tension measurements will be conducted at an external collaborating institution (University of Tokyo Hospital), and all samples will be anonymized prior to transfer. The study has received approval from the institutional ethics review board.

Registered date

2026

Year

02

Month

26

Day

Last modified on

2026

Year

02

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069525