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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | adults patients undergoing surgeries under general anesthesia with suplaglottic airway devices | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |