UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010726
Receipt No. 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 2016/11/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email iloklee@korea.ac.kr

Sponsor
Institute Korea University
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2013 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 20 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
2013 Year 05 Month 15 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012536

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.