UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034547