UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024093 |
|---|---|
| Receipt number | R000027739 |
| Scientific Title | Evaluation of the difference of emergence agitation between sevoflurane and desflurane anesthesia with remifentanil |
| Date of disclosure of the study information | 2016/09/20 |
| Last modified on | 2018/01/13 23:08:18 |
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Basic information
Public title
Evaluation of the difference of emergence agitation between sevoflurane and desflurane anesthesia with remifentanil
Acronym
The effect of volatile anesthetics on emergence agitation
Scientific Title
Evaluation of the difference of emergence agitation between sevoflurane and desflurane anesthesia with remifentanil
Scientific Title:Acronym
The effect of volatile anesthetics on emergence agitation
Region
| Japan |
Condition
Condition
thyroid diseases
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the degree of emergence agitation between sevoflurane and desflurane anesthesia with remifentanil
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of emergence agitation evaluated by modified pediatric anesthesia emergence delirium (PAED) scale
Key secondary outcomes
Time to extubation
Post-operative pain evaluated by numerical rating scale
Postoperative nausea and vomiting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Sevoflurane anesthesia with remifentanil
Interventions/Control_2
Desflurane anesthesia with remifentanil
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
Adult patients equal to or more than 20 years old who undergo operation under general anesthesia for thyroid diseases
Key exclusion criteria
Patients with body mass index more than 35
Patients with psychiatric disorder
Patients contraindicated against suxamethonium
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Suzuki |
Organization
Keio University School of Medicine
Division name
Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
takeshi-su@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Suzuki |
Organization
Keio University School of Medicine
Division name
Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
takeshi-su@a7.keio.jp
Sponsor or person
Institute
Department of Anesthesiology, Keio University School of Medicine
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
Address
Tel
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 | 09 | Month | 20 | 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
| 2016 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 26 | 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
| 2016 | Year | 09 | Month | 17 | Day |
Last modified on
| 2018 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027739
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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