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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031153
Receipt No. R000035479
Scientific Title Potentiating effects of sevofluane on rocuronium-induced neuromuscular block in elderly patients
Date of disclosure of the study information 2018/02/05
Last modified on 2020/06/05

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Basic information
Public title Potentiating effects of sevofluane on rocuronium-induced neuromuscular block in elderly patients
Acronym Potentiating effects of sevofluane on rocuronium-induced neuromuscular block in elderly patients
Scientific Title Potentiating effects of sevofluane on rocuronium-induced neuromuscular block in elderly patients
Scientific Title:Acronym Potentiating effects of sevofluane on rocuronium-induced neuromuscular block in elderly patients
Region
Japan

Condition
Condition surgical patients undergoing general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Duration of rocuronium-induced neuromuscular block during sevoflurane anesthesia is compared with that during propofol anesthesia in elderly patients.Also in younger adult patients, duration of rocuronium-induced neuromuscular block is measured during sevoflurane and propofol anesthesia. Between elderly and yonger adult, the data will be compared.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes recovery time of post-tetanic count
recovery time of train-of-four count
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sevoflurane anesthesia
Interventions/Control_2 propofol anesthesia
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 Patients with ASA classification 1-3
Patients consented to attend in this study
Key exclusion criteria Patients having allergic factor to neuromuscular blocking agents and reversal agents
Patients with ASA classification 4-6
Patients with BMI>30 or <18.5
Patients with neuromuscular diseases
Patients with liver dysfunction
Target sample size 80

Research contact person
Name of lead principal investigator
1st name OSAMU
Middle name
Last name KITAJIMA
Organization Nihon University Itabashi Hospital
Division name Anesthesiology
Zip code 1738610
Address 30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL 0339728111
Email kitajima.osamu@nihon-u.ac.jp

Public contact
Name of contact person
1st name OSAMU
Middle name
Last name KITAJIMA
Organization Nihon University Itabashi Hospital
Division name Anesthesiology
Zip code 1738610
Address 30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL 0339728111
Homepage URL
Email kitajima.osamu@nihon-u.ac.jp

Sponsor
Institute Nihon University Itabashi Hospital
Institute
Department

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 Nihon University Itabashi Hospital
Address 30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
Tel 0339728111
Email kitajima.osamu@nihon-u.ac.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
2018 Year 02 Month 05 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035479
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035479
Number of participants that the trial has enrolled 68
Results RESULTS: As shown in the table, there were significant differences between groups, and both F-PTC and F-T1 were significantly prolonged by S in the elderly compared to the young adults.
Results date posted
2020 Year 06 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Patients undergoing 2-3 hours of surgery under general anesthesia in the central operating room of Itabashi Hospital, Nihon University School of Medicine
Participant flow Patients undergoing 2-3 hours of surgery under general anesthesia in the central operating room of the Itabashi Hospital, Nihon University School of Medicine, who gave their consent
Adverse events none
Outcome measures Time of first T1 appearance after first dose of muscle relaxant
Time of first PTC appearance after first dose of muscle relaxant
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 02 Month 05 Day
Date of IRB
2018 Year 02 Month 05 Day
Anticipated trial start date
2018 Year 02 Month 06 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 02 Month 10 Day
Date analysis concluded
2019 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 05 Day
Last modified on
2020 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035479

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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