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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041666
Receipt No. R000047547
Scientific Title Effects of sugammadex injection speed on laryngeal airway patency in anesthetized patients with supraglottic airway devices :randomized controlled study
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/03

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Basic information
Public title Effects of sugammadex injection speed on laryngeal airway patency in anesthetized patients with supraglottic airway devices :randomized controlled study
Acronym Effects of sugammadex injection speed on laryngeal airway patency
Scientific Title Effects of sugammadex injection speed on laryngeal airway patency in anesthetized patients with supraglottic airway devices :randomized controlled study
Scientific Title:Acronym Effects of sugammadex injection speed 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 an hypothesis that the difference of sugammadex injection speed 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 Not applicable

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 Double blind -all involved 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 bolus injection of sugammadex
Interventions/Control_2 slow continuous infusion of sugammadex
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
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 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 who have coagulation abnormality
5)Patients whom supraglottic airway devices don't fit
6)Patients who are under tubal feeding
7)Patients who have the history of larynx disease
8)Patients who take anti-convulsion drugs
9)Patients who have the history of being intubated within one month
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
Email 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
Email shirohisono@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email 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
2020 Year 10 Month 01 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
2020 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2022 Year 03 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
2020 Year 09 Month 03 Day
Last modified on
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047547

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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