UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between onset of rocuronium-induced neuromuscular block and cardiac output in elderly patients
Title of the study (Brief title)	Rocuronium and CO
Region	Japan

Condition
Condition	Surgical patients requiring general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In elderly patients, onset of rocuronium-induced neuromuscular block markedly varies among individual patients and tends to delay when compared with younger adults. It is anticipated that the delayed onset of the action of rocuronium may relate to the difference in cardiac output. We will examine a correlation between the onset time of rocuronium and cardiac output and hope to contribute to safe tracheal intubation in elderly patients.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	onset time of rocuronium-induced neuromuscular block at the adductor pollicis muscle and arterial pressure based cardiac output
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A correlation between onset of the action of rocuronium 1mg/kg and arterial pressure cardiac output will be analyzed.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients aged 65 years old and above 2) ASA risk classification 1, 2 and 3 3) Patients requiring invasive arterial pressure and arterial pressure based cardiac output 4) Patients consented to participate in this study
Key exclusion criteria	1) Not satisfy selection criteria noted above 2) Patients having allergic factors to neuromuscular blocking agents 3) ASA risk 4 and above 4) BMI 30 and above or below 18.5
Target sample size	50

Research contact person
Name of lead principal investigator	Takahiro Suzuki
Organization	Nihon University School of Medicine
Division name	Department of Anesthesiology
Address	30-1 Oyaguchi-Kamimachi Itabashi-Ku Tokyo
TEL	03-3972-8111
Email	suzuki.takahiro@nihon-u.ac.jp

Public contact
Name of contact person	Takahiro Suzuki
Organization	Nihon University School of Medicine
Division name	Department of Anesthesiology
Address	30-1 Oyaguchi-Kamicho, Itabshi-ku, Tokyo
TEL	03-3972-8111
Homepage URL
Email	suzuki.takahiro@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine Department of Anesthesiology
Institute
Department

Funding Source
Organization	Departmental funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	日本大学医学部附属板橋病院(東京都)

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 10 Day
Anticipated trial start date	2012 Year 08 Month 27 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 21 Day
Last modified on	2018 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010264