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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05951842
Other study ID # 3-2017-0378
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 16, 2018
Est. completion date February 28, 2020

Study information

Verified date July 2023
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 28, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gangnam Severance Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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