UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020500 |
|---|---|
| Receipt number | 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 20:03:04 |
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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
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
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023594
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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