Anesthesia, TIVA, Balanced Anesthesia, NK Cell

Not Applicable

Withdrawn

• Conditions: Colorectal Cancer
• Interventions: Drug: anesthetic method

• Registration Number: NCT05951842
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-01
• Study Start: 2018-04-16
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVA group	anesthetic method	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
Balanced anesthesia group.	anesthetic method	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,

Primary Outcome Measures

Name	Time	Method
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.