NCT04891146

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 17, 2021

Last Update Submit

May 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    systemic inflammatory immune index calculated by (platelet x neutrophil)/lymphocyte

    preoperative SII noted, postoperative 2.hour noted and postoperative 24.hour noted

Study Arms (2)

Inhalation anesthesia

Sevoflurane for opioid remifentanyl used

Other: Systemic inflammatory immmune index

Total Intravenous Anesthesia

Propofol for opioid remifentanyl used

Other: Systemic inflammatory immmune index

Interventions

Systemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count

Inhalation anesthesiaTotal Intravenous Anesthesia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

major abdominal cancer patients between 18-85 years included. 40 patients in sevoflurane group and 44 patients in TIVA group collected

You may qualify if:

  • major abdominal cancer surgeries

You may not qualify if:

  • blood transfusion in last 72 hours
  • patients with infection
  • hematologic malignancy
  • patient controlled analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Research and Trainee Hospital

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Gastrointestinal NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Arsen Gungor

    arsen.gungor@hotmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist

Study Record Dates

First Submitted

March 17, 2021

First Posted

May 18, 2021

Study Start

March 5, 2020

Primary Completion

September 15, 2020

Study Completion

December 12, 2020

Last Updated

May 18, 2021

Record last verified: 2021-03

Locations