UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012536