UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Title of the study (Brief title)	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	Amane Konishi
Organization	Ehime University Graduate School of Medicine
Division name	Department of Anesthesia and Perioperative Medicine
Address	Ehime Prefecture Toon City Shitsukawa
TEL	089-960-5383
Email	konishi.amane.cs@ehime-u.ac.jp

Public contact
Name of contact person	Amane Konishi
Organization	Ehime University Graduate School of Medicine
Division name	Department of Anesthesia and Perioperative Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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