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Status unknownNCT03273231Updated Jan 16, 2019

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

An interventional study of Ketamine and Saline in Colorectal Cancer, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by Yonsei University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    control group

    0.9% saline solution

    Drug: Saline

Interventions

  • DrugKetamine

    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.

  • DrugSaline

    0.9% saline solution

05

What researchers measure

Primary outcomes

  1. natural killer cell cytotoxicity

    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

    Time frame: Baseline

  2. natural killer cell cytotoxicity

    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

    Time frame: 1 hour after surgery

  3. natural killer cell cytotoxicity

    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

    Time frame: postoperative day 1

  4. natural killer cell cytotoxicity

    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

    Time frame: postoperative day 2

Secondary outcomes

  1. proinflammatory cytokine

    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

    Time frame: Baseline

  2. proinflammatory cytokine

    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

    Time frame: 1 hour after surgery

  3. proinflammatory cytokine

    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

    Time frame: postoperative day 1

  4. proinflammatory cytokine

    Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.

    Time frame: postoperative day 2

  5. recurrence

    Cancer recurrence is evaluated 1 year after surgery.

    Time frame: 1 year after surgery

  6. metastasis

    Cancer metastasis is evaluated 1 year after surgery.

    Time frame: 1 year after surgery

06

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
    Recruiting
07

References and documents

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. PubMed 33532995 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03273231
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 6, 2017
Start date
Sep 1, 2017
Primary completion
Jul 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Jan 16, 2019

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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