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Trial registered on ANZCTR


Registration number
ACTRN12617000434392
Ethics application status
Approved
Date submitted
17/10/2015
Date registered
24/03/2017
Date last updated
24/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of different anesthesia techniques on intraoperative stress-induced immunosuppression in patients undergoing radical esophagectomy'
Scientific title
Evaluation of whether different anesthesia techniques can affect intraoperative stress-induced immunosuppression in patients undergoing radical esophagectomy.
Secondary ID [1] 287687 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients undergoing radical esophagectomy 296524 0
Oesophageal cancer 299995 0
Immunosupression 300355 0
Condition category
Condition code
Cancer 296785 296785 0 0
Oesophageal (gullet)
Anaesthesiology 299875 299875 0 0
Anaesthetics
Surgery 299886 299886 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing radical esophagectomy were randomly assigned to one of the two groups. In group I (n=20), patients received total intravenous general anesthesia (Group TIVA); in group II (n=20), patients received total intravenous general anesthesia combined with thoracic epidural anesthesia (Group TIVA+TEA). Each test solution was prepared in a syringe by the first investigator, who was also responsible for subject grouping. Under sterile conditions, a thoracic epidural catheter was placed via the T7–8 interspace and was advanced 3–4 cm cephalad by the first investigator. A test dose of 1% lidocaine 5 mL, alone, was then given by the first investigator via the thoracic epidural catheter, followed by 0.375% ropivacaine 5 mL, to produce a bilateral segmental sensory block to pinprick between the T6 and L4 dermatomes, or given 10mL normal saline. Then neuraxial block was maintained with 0.375% ropivacaine 5 mL/h or normal saline 5 mL/h throughout the surgical procedure by the second anaesthesiologist. Entropy index was used to maintain the depth of anesthesia to a certain level. Plasma levels of stress hormones and cytokines were assessed before surgery and as well as 1 and 3 hours after the beginning of surgery.
Intervention code [1] 293081 0
Treatment: Drugs
Comparator / control treatment
The Group TIVA+TEA patients received 0.375% ropivacaine 5 mL/h during surgery, while the control group patients received 5 mL/h normal saline as placebo via the thoracic epidural catheter.
Control group
Placebo

Outcomes
Primary outcome [1] 296389 0
Immunosuppression, assessed by serum assay for plasma cortisol, adrenocorticotropic hormone
Timepoint [1] 296389 0
before surgery and as well as 1 and 3 hours after the beginning of surgery
Secondary outcome [1] 327897 0
Composite outcome of plasma IL-6 and IL-10.
Timepoint [1] 327897 0
before surgery and as well as 1 and 3 hours after the beginning of surgery.

Eligibility
Key inclusion criteria
40 patients, of ASA physical status 1-3 adult patients, undergoing elective surgery for radical esophagectomy were included in this prospective randomized, double-blind, placebo-controlled trial.
Minimum age
29 Years
Maximum age
78 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
contraindications for receiving TEA, pre-existing cardiovascular diseases, preoperative treatment with opioids, non-steroidal anti-inflammatory drugs, or other immunomodulatory substances, infection, immune and endocrine system disorders and communication barriers.

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)
Allocation concealment was established by placing the randomization sequence in consecutively numbered, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
use of computer-generated codes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
a=0.05, 1-beta=0.8, a P-value of ,0.05 was considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7253 0
China
State/province [1] 7253 0
Shanghai

Funding & Sponsors
Funding source category [1] 292241 0
Government body
Name [1] 292241 0
National Natural Science Foundation of China
Address [1] 292241 0
No.83 Shuangqing Road Haidian District Beijing China,100085
Country [1] 292241 0
China
Primary sponsor type
Government body
Name
National Natural Science Foundation of China
Address
No.83 Shuangqing Road Haidian District Beijing China,100085
Country
China
Secondary sponsor category [1] 290917 0
None
Name [1] 290917 0
Address [1] 290917 0
Country [1] 290917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293706 0
Fudan University Cancer Hospital Ethics Committee
Ethics committee address [1] 293706 0
Fudan University, Shanghai Cancer Center,
No.270 Dong-an Road, Shanghai,
P. R. China, PC 200032
Ethics committee country [1] 293706 0
China
Date submitted for ethics approval [1] 293706 0
02/12/2014
Approval date [1] 293706 0
29/12/2014
Ethics approval number [1] 293706 0
47-12

Summary
Brief summary
With exposure to severe food safety issues especially in China, the global incidence of cancer has risen dramatically, although survival rate of cancer patients is improving due to the modern medical technology, cancer is the second most common cause of death, exceeded only by heart disease and accounting for one in every four deaths. Although surgery remains the most effective treatment of potentially curable solid tumors, anesthesiologists shoulder the responsibility to minimize worsen fragile immune function of cancer patients in perioperative period. The trial which investigated whether different anesthesia techniques could affect intraoperative stress-induced immunosuppression in patients undergoing radical esophagectomy has significant clinical practical significance
and this trial is fully in line with the Declaration of Helsinki human trials, so the ethics committee unanimously supported the trial adoption.
Trial website
www.shca.org.cn/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61038 0
Dr Jing Wang
Address 61038 0
Department of Anaesthesiology,Fudan University, Shanghai Cancer Center,
No.270 Dong-an Road, Shanghai, P. R. China, PC 200032.
Country 61038 0
China
Phone 61038 0
86-21-64175590
Fax 61038 0
Email 61038 0
nancy1248@sina.com
Contact person for public queries
Name 61039 0
Dr Changhong Miao
Address 61039 0
Department of Anaesthesiology,Fudan University, Shanghai Cancer Center,
No.270 Dong-an Road, Shanghai, P. R. China, PC 200032.
Country 61039 0
China
Phone 61039 0
86-21-64175590
Fax 61039 0
Email 61039 0
miaochanghong966@sia.com
Contact person for scientific queries
Name 61040 0
Dr Yun Zhu
Address 61040 0
Department of Anaesthesiology,Fudan University, Shanghai Cancer Center,
No.270 Dong-an Road, Shanghai, P. R. China, PC 200032.
Country 61040 0
China
Phone 61040 0
86-21-64175590
Fax 61040 0
Email 61040 0
yunzhush66@sina.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary