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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030263
Receipt No. 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 2019/06/17

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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
Email 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
Email rudy_sippo@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email 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
2021 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
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034547

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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