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

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Drug: Saline; Drug: Ketamine

• Registration Number: NCT03273231
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patient between 20 and 80 of age with ASA physical status Ⅰ-Ⅲ
• patient scheduled for laparoscopic colorectal cancer resection

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Saline	0.9% saline solution
ketamine group	Ketamine	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.

Primary Outcome Measures

Name	Time	Method
natural killer cell cytotoxicity	postoperative day 2	Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

Secondary Outcome Measures

Name	Time	Method
metastasis	1 year after surgery	Cancer metastasis is evaluated 1 year after surgery.
recurrence	1 year after surgery	Cancer recurrence is evaluated 1 year after surgery.
proinflammatory cytokine	postoperative day 2	Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of