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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020500
Receipt No. R000023594
Scientific Title Changes of airway protective function during recovery of general anesthesia
Date of disclosure of the study information 2016/01/08
Last modified on 2018/12/03

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Basic information
Public title Changes of airway protective function during recovery of general anesthesia
Acronym Recovery of general anesthesia and airway protective function
Scientific Title Changes of airway protective function during recovery of general anesthesia
Scientific Title:Acronym Recovery of general anesthesia and airway protective function
Region
Japan

Condition
Condition Patients undergoing surgeries under general anesthesia
Classification by specialty
Gastroenterology Surgery in general Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test a hypothesis that neuromuscular antagonists reciver airway protective function during recovery from general anesthesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Barrier pressure (lower esophageal sphincter pressure minus gastric pressure)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous administration of sugammadex
Interventions/Control_2 Intravenous administration of neostigmine
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 Female
Key inclusion criteria Adult females undergoing surgeries under general anesthesia in Chiba University hospital
Key exclusion criteria 1) Patients with allergies for drugs used during anesthesia
2) Patients with severe co-morbidities
3) Patients with coagulopathy
4) Patients undergoing emergent surgery
5) Patients with full stomach
6) Patients who had upper gastrointestinal surgeries
7) Patients with GER
8) Obese patients with BMI greater than 30 kg/m2
9) Patients with renal dysfunction
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruhiko Ishikawa
Organization Graduate School of Medicine, Chiba University
Division name Department of Anesthesiology
Zip code
Address 1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL 043-222-7171
Email tishikawa@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiroh Isono
Organization Graduate School of Medicine, Chiba University
Division name Department of Anesthesiology
Zip code
Address 1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL 043-222-7171
Homepage URL
Email shirohisono@yahoo.co.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Grant from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 08 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
2014 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 08 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023594

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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