UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031153 |
|---|---|
| Receipt number | 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 09:39:57 |
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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
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
kitajima.osamu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
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
Nihon University Itabashi Hospital
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
Tel
0339728111
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035479
