UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019690 |
|---|---|
| Receipt number | R000022751 |
| Scientific Title | The effect of remifentanil on emergence agitation after desflurane anesthesia |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2018/01/13 23:07:12 |
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Basic information
Public title
The effect of remifentanil on emergence agitation after desflurane anesthesia
Acronym
The effect of remifentanil on emergence agitation
Scientific Title
The effect of remifentanil on emergence agitation after desflurane anesthesia
Scientific Title:Acronym
The effect of remifentanil on emergence agitation
Region
| Japan |
Condition
Condition
Patients undergoing surgery for thyroid disease
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether remifentanil can attenuate the degree of emergence agitation after desflurane anesthesia, compared with the historical control without remifentanil administration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of emergence agitation evaluated by the modified pediatric anesthesia emergence delirium scale
Key secondary outcomes
Time to extubation
Visual analogue scale
Postoperative nausea and vomotting
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Adult patients undergoing operation for throid diseases
Key exclusion criteria
Patients with GCS equal to or less than 14, psychiatry diseases, mental retardation, or obesity with BMI>35
Target sample size
60
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 160-8582 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 160-8582 Japan
TEL
03-3353-1211
Homepage URL
takeshi-su@a7.keio.jp
Sponsor or person
Institute
Ito Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Keio University School of Medicine
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
| 2015 | Year | 11 | Month | 10 | 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
| 2015 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients, who met the inclusion criteria, underwent operation under general anesthesia with desflurane and remifentanil. Emergence agitation was evaluated using the scoring system after operation and before extubation. Time to extubation, VAS and PONV were also recorded. These measurements were compared with those of historical control which didn't receive remifentanil adminostration.
Management information
Registered date
| 2015 | Year | 11 | Month | 08 | 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=R000022751
