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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025051
Receipt No. R000028827
Scientific Title Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Date of disclosure of the study information 2016/11/29
Last modified on 2017/05/07

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Basic information
Public title Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Acronym Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Scientific Title Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Scientific Title:Acronym Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Region
Japan

Condition
Condition reperfusion injury
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In isolated lung ventilation, it is known that the non-ventilatory side blood flow decreases and the cytokine associated with reperfusion injury increases after restarting bilateral ventilation. Disorders of the lung are the most frequent complications after the operation of the isolated lung ventilation, and anesthesia management that prevents pulmonary complications is necessary. On the other hand, dexmedetomidine has been reported to have anti-inflammatory and antioxidative effects, and it has been reported that reperfusion injury due to artificial heart-lung and liver prying technique and suppression of elevation of inflammatory cytokines can be suppressed. However, the effect of dexmedetomidine on reperfusion injury associated with isolated lung ventilation is unknown. If dexmedetomidine has an action of suppressing reperfusion injury due to isolated pulmonary ventilation, it can contribute to prevention of pulmonary complications in isolated lung ventilation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Inflammatory cytokines in serum
Key secondary outcomes Vital, blood gas analysis, postoperative pain, resected lung weight, general blood sampling before and after surgery, extent of postoperative sedation, amount of urine, postoperative complications, days of stay in ICU, days to stay in hospital etc

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dexmedetomidine administered group
Interventions/Control_2 Control/Saline group
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who undergo lung resection with isolated lung ventilation and enter ICU after surgery
Key exclusion criteria Allergic to Dexmedetomidine
lung and systemic inflammatory diseases
BMI 35 over
reoperative patients
patients with impaired cardiac function
Hugh Jones classification 4 or more
autoimmune disease
immunosuppressive agent administration
Patients who are not indicated for extramembrane anesthesia
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Amane Konishi
Organization Ehime University Graduate School of Medicine
Division name Department of Anesthesia and Perioperative Medicine
Zip code
Address Ehime Prefecture Toon City Shitsukawa
TEL 089-960-5383
Email konishi.amane.cs@ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Amane Konishi
Organization Ehime University Graduate School of Medicine
Division name Department of Anesthesia and Perioperative Medicine
Zip code
Address Ehime Prefecture Toon City Shitsukawa
TEL 089-960-5383
Homepage URL
Email konishi.amane.cs@ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine
Department of Anesthesia and Perioperative Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 愛媛大学医学部付属病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 29 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
2014 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
2016 Year 02 Month 01 Day
Date of closure to data entry
2016 Year 02 Month 01 Day
Date trial data considered complete
2016 Year 02 Month 01 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 29 Day
Last modified on
2017 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028827

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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