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Trial record 63 of 1002 for:    colon cancer AND resection

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

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ClinicalTrials.gov Identifier: NCT03273231
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Ketamine Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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




Primary Outcome Measures :
  1. natural killer cell cytotoxicity [ Time Frame: Baseline ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

  2. natural killer cell cytotoxicity [ Time Frame: 1 hour after surgery ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

  3. natural killer cell cytotoxicity [ Time Frame: postoperative day 1 ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

  4. natural killer cell cytotoxicity [ Time Frame: postoperative day 2 ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).


Secondary Outcome Measures :
  1. proinflammatory cytokine [ Time Frame: Baseline ]
    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

  2. proinflammatory cytokine [ Time Frame: 1 hour after surgery ]
    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

  3. proinflammatory cytokine [ Time Frame: postoperative day 1 ]
    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

  4. proinflammatory cytokine [ Time Frame: postoperative day 2 ]
    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

  5. recurrence [ Time Frame: 1 year after surgery ]
    Cancer recurrence is evaluated 1 year after surgery.

  6. metastasis [ Time Frame: 1 year after surgery ]
    Cancer metastasis is evaluated 1 year after surgery.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273231


Contacts
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Contact: Jin Sun Cho, MD 82-2-2228-5448 chjs0214@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jin Sun Cho, MD    82-2-2228-5448    chjs0214@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03273231     History of Changes
Other Study ID Numbers: 4-2017-0475
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action