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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023479
Receipt No. R000027036
Scientific Title Comparion of the infusion rate of rocuronium necessary for obtain adequate surgical muscle relaxation between before and during hepatectomy with Pringle maneuver.
Date of disclosure of the study information 2016/08/08
Last modified on 2018/05/24

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Basic information
Public title Comparion of the infusion rate of rocuronium necessary for obtain adequate surgical muscle relaxation between before and during hepatectomy with Pringle maneuver.
Acronym Comparion of the infusion rate of rocuronium between before and during hepatectomy with Pringle maneuver.
Scientific Title Comparion of the infusion rate of rocuronium necessary for obtain adequate surgical muscle relaxation between before and during hepatectomy with Pringle maneuver.
Scientific Title:Acronym Comparion of the infusion rate of rocuronium between before and during hepatectomy with Pringle maneuver.
Region
Japan

Condition
Condition Surgical patients requiring hepatectomy with Pringle maneuver
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate a continuous infusion rate of rocuronium necessary for obtain optimal muscle relaxation, before and during hepatectomy with Pringle maneuver.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes continuous infusion rate for obtain muscle relaxasion(before, during, and after Pringle maneuver)
Key secondary outcomes measured blood concentration of rocuronium during stable state of optimalmuscle relaxation

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We adjust a continuous rocuronium infusion rate to keep T1 twitch hight from 3 to 10% with acceleromyography on the adductor pollicis in response to electrical stimulation of the ulnar nerve, also keep T1 hight to the same level during a Pringle maneuver by changing an infusion rate of rocuronium.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)ASA physical status 1~3
2)age=>20
3)total venous anesthesia with propofol
4)Operation time=>3hours
5)written informed consent was obtained from the patients before the surgery
Key exclusion criteria excluded if any one of the following criteria applied:
1) probably pregnant
2) abnormal serum electrolytes (Na +, K +, or Cl-)
3) renal dysfunction (serum creatinine greater than 2.0 mg/dl)
4) liver dysfunction (ALT and/or AST beyond twice the normal range)
5) ICG15=>15%
6) Child-Pugh classification=>B
7) emaciation (body mass index (BMI) less than 17), obesity (BMI more than 30)
8) neuromuscular disorders,
9) a history of hypersensitive reaction to Rb,
10) a history of treatment with drugs known to interact with Rb, such as aminoglycoside antibiotics, anticonvulsants, formulation lithium, or magnesium
11) hypothermia during anesthesia
12) systemic allergy
13) inappropriate patients judged by physician-in-charge
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Kajiura
Organization Saitama Medical Center, Jichi Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 1-847, Amanuma-cho, Oomiya-ku, Saitama 330-8503, Japan
TEL 048-647-2111
Email kajiura-hki@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kajiura
Organization Saitama Medical Center, Jichi Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 1-847, Amanuma-cho, Oomiya-ku, Saitama 330-8503, Japan
TEL 048-647-2111
Homepage URL
Email kajiura-hki@umin.ac.jp

Sponsor
Institute Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Jichi Medical University
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
2016 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

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 06 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 08 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2018 Year 04 Month 27 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027036

Research Plan
Registered date File name
2017/04/03 肝切臨床研究.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/07/28 患者データ2.xlsx


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