UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010240
Receipt number R000011987
Scientific Title Rocuronium-induced neuromuscular block and reversibility with sugammadex at the corrugator supercilii and adductor pollicis muscles
Date of disclosure of the study information 2013/03/14
Last modified on 2015/11/26 22:37:50

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Basic information

Public title

Rocuronium-induced neuromuscular block and reversibility with sugammadex at the corrugator supercilii and adductor pollicis muscles

Acronym

Rocuronium and sugammadex at the corrugator supercilli

Scientific Title

Rocuronium-induced neuromuscular block and reversibility with sugammadex at the corrugator supercilii and adductor pollicis muscles

Scientific Title:Acronym

Rocuronium and sugammadex at the corrugator supercilli

Region

Japan


Condition

Condition

Surgical patients requiring general anesthesia

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will accelermyographically monitor rocuronium-induced neuromuscular blockade and the reversibility with sugammadex at the corrugator superciliiand adductor pollicis muscles.In this study, adequate doses of sugammadex for the reversal of neuromusclar block induced at the both muscles should be adjusted.In addition, we wll aim to elucidate which muscle should be monitored to evaluate adequte recovery of neuromusclar function.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Optimum dose of sugammadex for the reversal of neuromuscular blockade at the corrugator supercilii muscle.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients will recive sugammadex 2mg/kg when the height of the twich in a train of four(TOF) stimlation willbe maintained at 10% of the control, and the time requred for the facilitated recovery to a TOF ratio of 0.9 will be recorded.

Interventions/Control_2

The patients will recive sugammadex 4mg/kg when the height of the twich in a train of four(TOF) stimlation willbe maintained at 10% of the control, and the time requred for the facilitated recovery to a TOF ratio of 0.9 will be recorded.

Interventions/Control_3

The patients will recive sugammadex 4mg/kg when the height of the twich in a train of four(TOF) stimlation willbe maintained at 10% of the control, and recorded the difference in the speed of recovery from rocuronium-induced neuromuscular block in the corrugator supercilii and adductor pollicis muscles.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients aged 20 years old and above
2) ASA risk classification 1 and 2
3) Patients consented to participate in this study

Key exclusion criteria

1)Patients having allergic factors to neuromuscular blocking agents
2) ASA risk 4 and above
3) BMI 30 and above or below 18.5
4)Patients having hepatic and renal disorders

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Suzuki

Organization

Nihon University of Medicine

Division name

Department of Anesthesiology

Zip code


Address

30-1 Oyaguchi-Kamimachi Itabashi-Ku Tokyo

TEL

03-3972-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Nihon University of Medicine

Division name

Department of Anesthesiology

Zip code


Address


TEL

03-3972-8111

Homepage URL


Email



Sponsor or person

Institute

Nihon University of Medicine Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Nihon University of Medicine Department of Anesthesiology

Organization

Division

Category of Funding Organization

Other

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

2013 Year 03 Month 14 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

2012 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 03 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

2013 Year 03 Month 14 Day

Last modified on

2015 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name