Back to resultsThe Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ketamine
Saline
Sponsored by
About this trial
This is an interventional other trial for Colorectal Cancer
Eligibility 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
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ketamine group
control group
Arm Description
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.
0.9% saline solution
Outcomes
Primary Outcome Measures
natural killer cell cytotoxicity
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
natural killer cell cytotoxicity
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
natural killer cell cytotoxicity
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
natural killer cell cytotoxicity
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Secondary Outcome Measures
proinflammatory cytokine
Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
proinflammatory cytokine
Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
proinflammatory cytokine
Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
proinflammatory cytokine
Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
recurrence
Cancer recurrence is evaluated 1 year after surgery.
metastasis
Cancer metastasis is evaluated 1 year after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03273231
Brief Title
The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
Official Title
The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ketamine group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
0.9% saline solution
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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 Type
Drug
Intervention Name(s)
Saline
Intervention Description
0.9% saline solution
Primary Outcome Measure Information:
Title
natural killer cell cytotoxicity
Description
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Time Frame
Baseline
Title
natural killer cell cytotoxicity
Description
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Time Frame
1 hour after surgery
Title
natural killer cell cytotoxicity
Description
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Time Frame
postoperative day 1
Title
natural killer cell cytotoxicity
Description
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Time Frame
postoperative day 2
Secondary Outcome Measure Information:
Title
proinflammatory cytokine
Description
Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
Time Frame
Baseline
Title
proinflammatory cytokine
Description
Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
Time Frame
1 hour after surgery
Title
proinflammatory cytokine
Description
Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
Time Frame
postoperative day 1
Title
proinflammatory cytokine
Description
Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.
Time Frame
postoperative day 2
Title
recurrence
Description
Cancer recurrence is evaluated 1 year after surgery.
Time Frame
1 year after surgery
Title
metastasis
Description
Cancer metastasis is evaluated 1 year after surgery.
Time Frame
1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Sun Cho, MD
Phone
82-2-2228-5448
Email
chjs0214@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Sun Cho, MD
Phone
82-2-2228-5448
Email
chjs0214@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33532995
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
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