The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection

Study Overview
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Brief Summary
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Systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. ketamine, a N-methyl-D-asparate receptor antangonist, has anti-inflammatory activity and opioid-sparing effect. This study investigate the effect of intraopertaive ketamine administration on immune function in patients undergoing laparoscopic colorectal cancer resection.

Official Title
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The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Ketamine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient between 20 and 80 of age with ASA physical status Ⅰ-Ⅲ patient scheduled for laparoscopic colorectal cancer resection Exclusion Criteria: ASA physical status Ⅳ severe hepatorenal disease heart failure infection increased intracranial pressure, seizure preoperative chemotherapy immune or endocrine disease metastasis to other organ problem with communication pregnancy body mass index > 35 kg/m2

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketamine group<br>Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery. | Drug: Ketamine<br>* Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.<br>|
| Placebo Comparator: control group<br>0.9% saline solution | Drug: Saline<br>* 0.9% saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| natural killer cell cytotoxicity | Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea). | Baseline | 
| natural killer cell cytotoxicity | Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea). | 1 hour after surgery | 
| natural killer cell cytotoxicity | Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea). | postoperative day 1 | 
| natural killer cell cytotoxicity | Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea). | postoperative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proinflammatory cytokine | Inflammtory response is assesssed by measuring levels of proinflammtory cytokines. | Baseline | 
| proinflammatory cytokine | Inflammtory response is assesssed by measuring levels of proinflammtory cytokines. | 1 hour after surgery | 
| proinflammatory cytokine | Inflammtory response is assesssed by measuring levels of proinflammtory cytokines. | postoperative day 1 | 
| proinflammatory cytokine | Inflammtory response is assesssed by measuring levels of proinflammtory cytokines. | postoperative day 2 | 
| recurrence | Cancer recurrence is evaluated 1 year after surgery. | 1 year after surgery | 
| metastasis | Cancer metastasis is evaluated 1 year after surgery. | 1 year after surgery |