Anesthesia, TIVA, Balanced Anesthesia, NK Cell

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05951842

Collaborator

(none)

Enrollment

Arms

22.4

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Anesthetic method was reported to have an impact on postoperative long-term outcome in cancer patients. In this study, we will investigate the effect of different anesthetic methods on NK cell activity, cytokine response and postoperative outcome in colorectal cancer patients undergoing CRS and HIPEC. We will compare propofol-based total intravenous anesthesia (TIVA) with balanced anesthesia to determine the effect of propofol, inhalation agent, and opioid on tumor genesis, recurrence, NK cell activity, cytokine response, and postoperative outcome.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: anesthetic method	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Differences Between the Effects of Total Intravenous Anesthesia (TIVA) and Balanced Anesthesia on NK Cell and Cytokine Response in Colorectal Cancer Patients Undergoing Cytoreductive Surgery and HIPEC(Hyperthermic Intraperitoneal Chemotherapy)

Actual Study Start Date :

Apr 16, 2018

Actual Primary Completion Date :

Feb 28, 2020

Actual Study Completion Date :

Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TIVA group In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. Other names: fresofol MCT 1% inj®; Fresenius kabi, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea	Drug: anesthetic method Patients will be assigned to one of the groups, TIVA group or Balanced anesthesia group. In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. In contrast, anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.
Experimental: Balanced anesthesia group. Anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group. Other names: Sojourn®, Kyongbo, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea,	Drug: anesthetic method Patients will be assigned to one of the groups, TIVA group or Balanced anesthesia group. In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. In contrast, anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.

Arm

Intervention/Treatment

Active Comparator: TIVA group

In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. Other names: fresofol MCT 1% inj®; Fresenius kabi, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea

Drug: anesthetic method

Patients will be assigned to one of the groups, TIVA group or Balanced anesthesia group. In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. In contrast, anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.

Experimental: Balanced anesthesia group.

Anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group. Other names: Sojourn®, Kyongbo, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea,

Drug: anesthetic method

Outcome Measures

Primary Outcome Measures

Postoperative immune function (NK cell count) [Postoperative day 1]
Postoperative immune function will be measured at baseline, POD#1, and POD#7. Postoperative immune function will be investigated by measuring NK cell count.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Colorectal cancer patients undergoing elective cytoreductive surgery and HIPEC (20-70 yrs old)
American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria:

Patients under 20 years old.
Patients with long-term steroid therapy or immunosuppressive therapy.
Patients with long-term NSAIDs therapy.
Patients who cannot communicate with other person or with cognitive disorder.
Patients who cannot read the consent form.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong Woo Han, Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT05951842

Other Study ID Numbers:

3-2017-0378

First Posted:

Jul 19, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Anesthetics

Study Results

No Results Posted as of Jul 19, 2023