- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04891146
The Effect of Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries
May 14, 2021 updated by: Arsen Güngör, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
The Effect of Inhalation Anesthesia and Total Intravenous Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries
The effects of different anesthesia methods on the immune system are variable.
In this study, we investigated the effect of inhalation anesthesia and total intravenous anesthesia on the SII value in major abdominal cancer surgeries.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The study was planned prospectively, observationally, on a total of 90 patients who underwent major abdominal cancer surgery.
84 patients were evaluated.
The patients were seperated in two groups as inhalation anesthesia and total intravenous anesthesia (TIVA).
The demographic data of the patients, type of cancer, type of surgery performed, ASA classification, preoperative chemotherapy intake, preoperative hemogram, postoperative 2nd and 24th hour hemogram, intraoperative and postoperative blood transfusion, and duration of surgery were recorded.
Platelet, neutrophil, lymphocyte and SII values were saved.
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey, 06200
- Dr. Abdurrahman Yurtaslan Oncology Research and Trainee Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
major abdominal cancer patients between 18-85 years included.
40 patients in sevoflurane group and 44 patients in TIVA group collected
Description
Inclusion Criteria:
- major abdominal cancer surgeries
Exclusion Criteria:
- blood transfusion in last 72 hours
- patients with infection
- hematologic malignancy
- patient controlled analgesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Inhalation anesthesia
Sevoflurane for opioid remifentanyl used
|
Systemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count
|
|
Total Intravenous Anesthesia
Propofol for opioid remifentanyl used
|
Systemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
investigate the effect of anesthesia management on the change of preoperative systemic inflammatory immune index(SII) and postoperative 2.hour and 24.hour SII value
Time Frame: preoperative SII noted, postoperative 2.hour noted and postoperative 24.hour noted
|
systemic inflammatory immune index calculated by (platelet x neutrophil)/lymphocyte
|
preoperative SII noted, postoperative 2.hour noted and postoperative 24.hour noted
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arsen Gungor, arsen.gungor@hotmail.com
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hu B, Yang XR, Xu Y, Sun YF, Sun C, Guo W, Zhang X, Wang WM, Qiu SJ, Zhou J, Fan J. Systemic immune-inflammation index predicts prognosis of patients after curative resection for hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):6212-22. doi: 10.1158/1078-0432.CCR-14-0442. Epub 2014 Sep 30.
- Lee JH, Kang SH, Kim Y, Kim HA, Kim BS. Effects of propofol-based total intravenous anesthesia on recurrence and overall survival in patients after modified radical mastectomy: a retrospective study. Korean J Anesthesiol. 2016 Apr;69(2):126-32. doi: 10.4097/kjae.2016.69.2.126. Epub 2016 Mar 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2020
Primary Completion (Actual)
September 15, 2020
Study Completion (Actual)
December 12, 2020
Study Registration Dates
First Submitted
March 17, 2021
First Submitted That Met QC Criteria
May 14, 2021
First Posted (Actual)
May 18, 2021
Study Record Updates
Last Update Posted (Actual)
May 18, 2021
Last Update Submitted That Met QC Criteria
May 14, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AbdurrahmanYAOTRH (Other Identifier: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
shared after published
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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