UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025413
Receipt number R000021535
Scientific Title Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and corrugator supercilii muscles
Date of disclosure of the study information 2017/01/01
Last modified on 2018/07/03 06:14:00

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Basic information

Public title

Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and
corrugator supercilii muscles

Acronym

Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and
corrugator supercilii muscles

Scientific Title

Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and
corrugator supercilii muscles

Scientific Title:Acronym

Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and
corrugator supercilii muscles

Region

Japan


Condition

Condition

patients undergoing elective surgery

Classification by specialty

Surgery in general Anesthesiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We compare the neuromuscular effects of rocuronium and rversal effects of sugammadex on adductor pollicis and corrugator supercilii muscles in surgical patients during inhalational or intravenous anesthesia.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the train of four(TOF) ratio of adductor pollicis and corrugator supercilii muscle after administration of ROC and sugammadex during inhalational or intravenous anesthesia

Key secondary outcomes

adverse effects of ROC and sugammadex and incidence of postoperative respiratory complications


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

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients are allocated to one of three groups, desflurane, sevoflurane, propofol.
Anesthetics use for general anesthesia.

desflurane

Interventions/Control_2

sevoflurane

Interventions/Control_3

propofol

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

ASA-PS 1-2 patients
over 15 years old

Key exclusion criteria

neuromuscular diseases
renal or liver dysfunction
allergy for rocuronium

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Nakatsuka

Organization

Kawasaki medical school

Division name

Department of anesthesiology and intensive care medicine

Zip code


Address

Matsushima577, Kurashiki city, Okayama

TEL

0864621111

Email

h.nakatsuka@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Keita Hazama

Organization

Kawasaki medical school

Division name

Department of anesthesiology and intensive care medicine

Zip code


Address

Matsushima577, Kurashiki city, Okayama

TEL

0864621111

Homepage URL


Email

k.hazama@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki medical school

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 01 Month 01 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

2016 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 15 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 12 Month 26 Day

Last modified on

2018 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021535


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name