UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047089 |
|---|---|
| Receipt number | R000053712 |
| Scientific Title | Effects of fentanyl concentration on laryngeal airway patency in anesthetized patients with supraglottic airway devices :randomized controlled study |
| Date of disclosure of the study information | 2022/03/06 |
| Last modified on | 2023/06/05 18:42:22 |
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Basic information
Public title
Effects of fentanyl concentration on laryngeal airway patency in anesthetized patients with supraglottic airway devices :randomized controlled study
Acronym
Effects of fentanyl concentration on laryngeal airway patency
Scientific Title
Effects of fentanyl concentration on laryngeal airway patency in anesthetized patients with supraglottic airway devices :randomized controlled study
Scientific Title:Acronym
Effects of fentanyl concentration on laryngeal airway patency
Region
| Japan |
Condition
Condition
adults patients undergoing surgeries under general anesthesia with suplaglottic airway devices
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test a hypothesis that the difference of fentanyl effect site concentration leads to different laryngeal airway patency.
Basic objectives2
Others
Basic objectives -Others
To explore whether mechanical parameters such as respiratory sound and respiratory resistance reflect changes of laryngeal airway patency.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
vocal cord angle
Key secondary outcomes
respiratory mechanics parameters such as respiratory sound and respiratory resistance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of fentanyl
Interventions/Control_2
No use of fentanyl
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Adult patients whose supraglottic airway devices use is supposed to be appropriate and who will be under general anesthesia for urological small surgery.
2)Patients who is categorized as American Society of Anesthesia-Physical status 1-3
3)male and female patients
4)Patients with informed
consent about this research
Key exclusion criteria
1)Patients who are at the risk of aspiration
2)Patients whose surgery will be laparoscopic
3)Patients who is under oxypathy
4)Patients whom supraglottic airway devices don't fit
5)Patients who are under tubal feeding
6)Patients who have the history of larynx disease
7)Patients who take anti-convulsion drugs
8)Patients who have the history of being intubated within one month
9)Patients whom acetaminophen and NSAIDs are inadequate to treat with
10)Patients who are thought to be inadequate by researchers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishibashi |
Organization
Chiba University Hospital
Division name
Depatment of Anesthesiology
Zip code
260-8677
Address
inohana1-8-1,Chuou ku ,Chiba City,Chiba Ken
TEL
043-222-7171
katsu1484@chiba-u.jp
Public contact
Name of contact person
| 1st name | Shiroh |
| Middle name | |
| Last name | Isono |
Organization
Chiba Graduate School of Medicine
Division name
Anesthesiology
Zip code
260-8677
Address
inohana1-8-1,Chuou ku ,Chiba City,Chiba Ken
TEL
043-222-7171
Homepage URL
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Graduate School of Medicine
Address
inohana1-8-1,Chuou ku ,Chiba City,Chiba Ken
Tel
043-226-2462
inohana-rinri@chiba-u.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
| 2022 | Year | 03 | Month | 06 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 05 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 05 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053712
