Anesthesia, TIVA, Balanced Anesthesia, NK Cell

NCT05951842 | Withdrawn

• 1 other identifier: 3-2017-0378
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Postoperative immune function (NK cell count)

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

  Postoperative day 1

Study Arms (2)

TIVA group

ACTIVE COMPARATOR

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

Balanced anesthesia group.

EXPERIMENTAL

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

Interventions

anesthetic method DRUG

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.

Balanced anesthesia group.; TIVA group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2018
• First Posted: July 19, 2023
• Study Start: April 16, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share