UMIN-CTR Clinical Trial

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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