UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060554 |
|---|---|
| Receipt number | R000069266 |
| Scientific Title | Assessment of Stress During Nasotracheal Intubation Using Salivary Amylase Activity: A Comparison Between Macintosh and Video Laryngoscopes |
| Date of disclosure of the study information | 2026/02/03 |
| Last modified on | 2026/02/02 16:10:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of Stress During Nasotracheal Intubation Using Salivary Amylase Activity: A Comparison Between Macintosh and Video Laryngoscopes
Acronym
Assessment of Stress During Nasotracheal Intubation Using Salivary Amylase
Scientific Title
Assessment of Stress During Nasotracheal Intubation Using Salivary Amylase Activity: A Comparison Between Macintosh and Video Laryngoscopes
Scientific Title:Acronym
Assessment of Stress During Nasotracheal Intubation Using Salivary Amylase
Region
| Japan |
Condition
Condition
Patients Undergoing Nasotracheal Intubation During General Anesthesia
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine whether different intubation methods influence stress responses.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary Amylase
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Nasotracheal intubation using a Macintosh laryngoscope
Interventions/Control_2
Nasotracheal Intubation Using a Video Laryngoscope
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with an ASA Physical Status of 1-2 undergoing general anesthesia with nasotracheal intubation
Key exclusion criteria
Smokers, patients with salivary secretion disorders, and patients taking antipsychotic medications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Aiji |
| Middle name | |
| Last name | Sato |
Organization
Aichi Gakuin University
Division name
department of anesthesiology, school of dentistry
Zip code
464-8651
Address
2-11 suemori-dori, chikusaku, nagoya, aichi
TEL
0527592111
bokuaiji@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Hashimoto |
Organization
Aichi Gakuin University
Division name
department of anesthesiology, school of dentistry
Zip code
464-8651
Address
2-11 suemori-dori, chikusaku, nagoya, aichi
TEL
0527592111
Homepage URL
mayumi84@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin University
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
The Ethics Committee of the School of Dentistry, Aichi Gakuin University
Address
1-100 kusumoto-cyo , chikusaku, nagoya
Tel
0527512561
isobe@dpc.agu.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
| 2026 | Year | 02 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 04 | 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
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 02 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069266
