UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010726 |
|---|---|
| Receipt number | R000012536 |
| Scientific Title | The effect of microemulsion propofol as an induction drug on the withdrawal response associated with an injection of rocuronium |
| Date of disclosure of the study information | 2013/05/15 |
| Last modified on | 2022/11/21 14:25:52 |
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Basic information
Public title
The effect of microemulsion propofol as an induction drug on the withdrawal response associated with an injection of rocuronium
Acronym
microemulsion propofol and rocuronium withdrawal
Scientific Title
The effect of microemulsion propofol as an induction drug on the withdrawal response associated with an injection of rocuronium
Scientific Title:Acronym
microemulsion propofol and rocuronium withdrawal
Region
| Asia(except Japan) |
Condition
Condition
elective surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
reduce the frequency and severity of pain during an injection of rocuronium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the withdrawal movement on injection of rocuronium could be attenuated by microemulsion propofol as an anesthetic induction agent.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
microemulsion propofol injection. observe withdrawal response of hand or are during injection, for few seconds
Interventions/Control_2
long-chain triglyceride emulsion propofol
Interventions/Control_3
active control group for anesthetic induction, conventional intravenous barbiturate,thiopental
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
| 54 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ASA (The American Society of Anesthesiologists) physical status 1 who were scheduled for elective surgery
Key exclusion criteria
Patients with a known allergy to propofol or thiopental, a history of seizures, cardiovascular defects, respiratory defects, renal insufficiency, hepatic impairment, a hypovolemic state, pregnancy or who were being treated with analgesics were excluded.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Il-Ok Lee |
Organization
Korea University
Division name
Anesthesiology and Pain Medicine
Zip code
Address
Gurodong-ro 148, guro-gu, Seoul, Korea
TEL
82-2-2626-1437
iloklee@korea.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Il-Ok Lee |
Organization
Korea University
Division name
Anesthesiology and Pain Medicine
Zip code
Address
gurodong-ro 148, guro-ku, Seoul, Republic of korea
TEL
82-2-2626-1437
Homepage URL
iloklee@korea.ac.kr
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
Funding Source
Organization
Korea University
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2013 | Year | 05 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 16 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 16 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012536
| 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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