Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000410055
Ethics application status
Approved
Date submitted
18/05/2010
Date registered
21/05/2010
Date last updated
21/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Anaesthetic Preconditioning on Lung Injury during One Lung Ventilation undergoing Transthoracic Esophagectomy
Scientific title
Comparison of Plasma interleukin-6 between sevoflurane preconditioning and non-conditioning groups in patients undergoing transthoracic esophagectomy
Secondary ID [1] 251791 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
esophageal cancer 257390 0
Condition category
Condition code
Anaesthesiology 257536 257536 0 0
Anaesthetics
Cancer 257564 257564 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the group T and group T/S, propofol and remifentanil will be administered to end organ concentrations of 5.0 microg ml-1 and 4.0 ng ml-1, respectively, using a target-controlled infusion (TCI) pump (Orchestra, Fresenius Vial, France) from induction of anesthesia.
In the group T/S, 30 minutes before induction of one lung ventilation, total intravenous anesthesia(TIVA) will be stopped and replaced by 2 vol% sevoflurane. Namely, group T/S will receive propofol and remifentanil, followed by 30 min sevoflurane inhalation, and then TIVA again during one lung ventilation.
Intervention code [1] 256499 0
Treatment: Drugs
Comparator / control treatment
Patients will be randomly assigned to 3 groups. One group will receive inhalational anesthesia with 2 vol% sevoflurane throughout the operation (group S), another group will receive total intravenous anesthesia (TIVA) with propofol 5 microgml-1 and remifentanil 4.0 ng ml-1 throughout the operation (group T) and the other group will receive TIVA and then shift to 2 vol% sevoflurane inhalation anesthesia for 30 minute before one lung ventilation, then receive TIVA again (group T/S).
Control group
Active

Outcomes
Primary outcome [1] 258448 0
interleukin-6 plasma levels assessed by blood analysis
Timepoint [1] 258448 0
just before the start of one lung ventilation and at end of operation
Secondary outcome [1] 264237 0
blood malondialdehyde
Timepoint [1] 264237 0
just before the start of one lung ventilation and at end of operation
Secondary outcome [2] 264238 0
chest radiography
Timepoint [2] 264238 0
immediately prior to the operation and postoperative 1 day
Secondary outcome [3] 264239 0
complications: anastomosis leakagewill be assessed clinically, arrhythmia by electrocardiogram (ECG), lung complications by physical signs and laboratory tests, and wound dehiscence will be assessed clinically
Timepoint [3] 264239 0
within 7 days, postoperatively, it will be assessed as problems arise

Eligibility
Key inclusion criteria
American Society of Anaesthesiologists physical status I-III undergoing transthoracic esophagectomy
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
high body temperature (over 37degrees celsius), increased levels of C-reactive protein (CRP) and white blood cell (WBC), administration nonsteroidal anti-inflammatory agent (NSAIDs) or corticosteroid within 3months, vital capacity (VC) or peak expiratoty volume at 1 minute (FEV1) less than 50% of expected.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 2634 0
Korea, Republic Of
State/province [1] 2634 0
seoul

Funding & Sponsors
Funding source category [1] 256986 0
Hospital
Name [1] 256986 0
Samsung Medical Center, Clinical Research Development Program grant
Country [1] 256986 0
Korea, Republic Of
Primary sponsor type
Individual
Name
Jie Ae Kim
Address
50 Ilwon-dong, Kangnam-gu, Seoul, 135-710
Country
Korea, Republic Of
Secondary sponsor category [1] 256250 0
Individual
Name [1] 256250 0
Gunn Hee Kim
Address [1] 256250 0
50 Ilwon-dong, Kangnam-gu, Seoul, 135-710
Country [1] 256250 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258996 0
Institutional review board
Ethics committee address [1] 258996 0
50 Ilwon-dong, Kangnam-gu, Seoul 135-710 South Korea
Ethics committee country [1] 258996 0
Korea, Republic Of
Date submitted for ethics approval [1] 258996 0
23/04/2009
Approval date [1] 258996 0
28/04/2009
Ethics approval number [1] 258996 0
2009-04-042

Summary
Brief summary
Pulmonary complication after one lung ventilation (OLV) is one of serious complications after transthoracic esophagectomy (TTE). The authors designed this study to investigate that the preconditioning of volatile anesthetics could decrease the production of pro-inflammatory cytokines or oxygen free radicals and decrease the development of pulmonary complications in the patients undergoing TTE. Forty-five adults undergoing TTE with OLV will be randomly assigned to receive sevoflurane anaesthesia (group S), total intravenous anaesthesia (TIVA) using propofol with remifentanil (group T), or sevoflurane preconditioning group (group T/S).The concentrations of plasma interleukin-6 (IL-6) and plasma malondialdehyde (MDA) will be assessed before and after OLV as the primary endpoint. The clinical outcome between group S and group T will be compared as the secondary endpoint.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31176 0
Address 31176 0
Country 31176 0
Phone 31176 0
Fax 31176 0
Email 31176 0
Contact person for public queries
Name 14423 0
Jie Ae Kim
Address 14423 0
50 Ilwon-dong, Kangnam-gu, Seoul,135-710
Country 14423 0
Korea, Republic Of
Phone 14423 0
+82 2 3410 0363
Fax 14423 0
Email 14423 0
jakim0813@yahoo.com
Contact person for scientific queries
Name 5351 0
Jie Ae Kim
Address 5351 0
50 Ilwon-dong, Kangnam-gu, Seoul,135-710
Country 5351 0
Korea, Republic Of
Phone 5351 0
+82 2 3410 0363
Fax 5351 0
Email 5351 0
jakim0813@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.