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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Ketamine; Drug: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
    • Contact: Jin Sun Cho, MD; Phone Number: 82-2-2228-5448; Email: chjs0214@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ketamine group; 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; 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.
Placebo Comparator: control group; 0.9% saline solution	Drug: Saline; 0.9% saline solution

What is the study measuring?

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).	postoperative day 1
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 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

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Cho JS, Kim NY, Shim JK, Jun JH, Lee S, Kwak YL. The immunomodulatory effect of ketamine in colorectal cancer surgery: a randomized-controlled trial. Can J Anaesth. 2021 May;68(5):683-692. doi: 10.1007/s12630-021-01925-3. Epub 2021 Feb 2.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 4-2017-0475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No