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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010727
Receipt No. R000012537
Scientific Title Effects of microemulsion propofol or desflurane on postoperative respiratory function in geriatrics
Date of disclosure of the study information 2013/05/15
Last modified on 2015/04/06

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Basic information
Public title Effects of microemulsion propofol or desflurane on postoperative respiratory function in geriatrics
Acronym TIVA vs. desflurane: effect on geriatric postoperative PFT
Scientific Title Effects of microemulsion propofol or desflurane on postoperative respiratory function in geriatrics
Scientific Title:Acronym TIVA vs. desflurane: effect on geriatric postoperative PFT
Region
Asia(except Japan)

Condition
Condition Elective surgery
Classification by specialty
Geriatrics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to compare the effect of microemulsion propofol or desflurane as anesthetic maintenance drug on postoperative respiratory function in geriatric patients.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Although there is a delay in awakening when using microemulsion propofol for maintenance of anesthesia in geriatrics compared to desflurane, its effects on postoperative respiratory function are same as those of desflurane if the anesthetic time is less than 3 hrs.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Uncontrolled
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 microemulsion propofol TIVA
Interventions/Control_2 desflurane anesthesia
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
65 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria ASA physical status 1-2 who was scheduled for elective orthopedic limb surgery
Key exclusion criteria Patients with a known allergy to propofol, a history of seizures, respiratory defects, renal insufficiency, hepatic impairment, a hypovolemic state, or who were being treated with analgesics were excluded.
Target sample size 60

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 Published

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
2013 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 20 Day
Last follow-up date
2014 Year 01 Month 24 Day
Date of closure to data entry
2014 Year 01 Month 27 Day
Date trial data considered complete
2014 Year 01 Month 28 Day
Date analysis concluded
2014 Year 01 Month 29 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 15 Day
Last modified on
2015 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012537

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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