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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 : Unknown
Verified January 2019 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : September 6, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE September 4, 2017
First Posted Date  ICMJE September 6, 2017
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • natural killer cell cytotoxicity [ Time Frame: Baseline ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
  • natural killer cell cytotoxicity [ Time Frame: 1 hour after surgery ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
  • natural killer cell cytotoxicity [ Time Frame: postoperative day 1 ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
  • natural killer cell cytotoxicity [ Time Frame: postoperative day 2 ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • proinflammatory cytokine [ Time Frame: Baseline ]
    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
  • proinflammatory cytokine [ Time Frame: 1 hour after surgery ]
    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
  • proinflammatory cytokine [ Time Frame: postoperative day 1 ]
    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
  • proinflammatory cytokine [ Time Frame: postoperative day 2 ]
    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
  • recurrence [ Time Frame: 1 year after surgery ]
    Cancer recurrence is evaluated 1 year after surgery.
  • metastasis [ Time Frame: 1 year after surgery ]
    Cancer metastasis is evaluated 1 year after surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
Official Title  ICMJE The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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.
  • Drug: Saline
    0.9% saline solution
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ketamine
  • Placebo Comparator: control group
    0.9% saline solution
    Intervention: Drug: Saline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 5, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03273231
Other Study ID Numbers  ICMJE 4-2017-0475
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Yonsei University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yonsei University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP