UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030263 |
|---|---|
| Receipt number | R000034547 |
| Scientific Title | Risk factors of recurarization after insufficient sugammadex administration: Effects of obesity and obstructive sleep apnea |
| Date of disclosure of the study information | 2017/12/05 |
| Last modified on | 2020/06/08 09:11:52 |
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Basic information
Public title
Risk factors of recurarization after insufficient sugammadex administration: Effects of obesity and obstructive sleep apnea
Acronym
Effects of obesity and obstructive sleep apnea on recurarization following insufficient sugammadex
Scientific Title
Risk factors of recurarization after insufficient sugammadex administration: Effects of obesity and obstructive sleep apnea
Scientific Title:Acronym
Effects of obesity and obstructive sleep apnea on recurarization following insufficient sugammadex
Region
| Japan |
Condition
Condition
patients with obesity, patients with obstructive sleep apnea, patients undergoing elective surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test a hypothesis that obesity slows recovery of the train-of four ratio when sugammadex is insufficient.
Basic objectives2
Others
Basic objectives -Others
To test a hypothesis that obesity increases incidence of recurarization following insufficient sugammadex
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TOF ratio recovery speed
Key secondary outcomes
Variables obtained from the neuromuscular monitoring,
background variables
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
infusion of insufficient sugammadex
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
elective surgical patients under general anesthesia: 20 non-obese patients (BMI less than 25kg/m2) and 20 obese patients (BMI greater than 30 kg/m2)
Key exclusion criteria
Exclusion criteria were 1) patients with severe comorbidities, 2) allergies for muscle relaxants, propofol and sugammadex, 3) patients undergoing surgeries undesirable for administration of rocuronium and sugammadex, and 4) patients taking drugs that influence rocuronium and sugammadex such as antiepileptic agents, estrogen preparation, rifampicin and verapamil, 5) patients who the researcher judged inappropriate as the subject
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Isono |
| Middle name | |
| Last name | Shiroh |
Organization
Chiba University
Division name
Department of Anesthesiology, Graduate School of Medicine
Zip code
2608670
Address
1-8-1 Inohana-cho, Chuo-ku, Chiba, 260-8670, Japan
TEL
+81-43-226-2155
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Muramatsu |
Organization
Chiba University
Division name
Department of Anesthesiology, Graduate School of Medicine
Zip code
260-8677
Address
1-8-1 Inohana-cho, Chuo-ku, Chiba, 260-8670, Japan
TEL
+81-43-226-2155
Homepage URL
rudy_sippo@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
Research Ethics Committee of Chiba university
Address
1-8-1 Inohana-cho, Chuo-ku, Chiba, 260-8670, Japan
Tel
+81-43-226-2155
igaku-rinri@office.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
| 2017 | Year | 12 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 06 | 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
| 2017 | Year | 12 | Month | 05 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034547
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
