NCT03273231

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

September 4, 2017

Last Update Submit

January 15, 2019

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

  • 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 1

  • natural killer cell cytotoxicity

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

    postoperative day 2

Secondary Outcomes (6)

  • proinflammatory cytokine

    Baseline

  • proinflammatory cytokine

    1 hour after surgery

  • proinflammatory cytokine

    postoperative day 1

  • proinflammatory cytokine

    postoperative day 2

  • recurrence

    1 year after surgery

  • +1 more secondary outcomes

Study Arms (2)

ketamine group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

0.9% saline solution

Drug: Saline

Interventions

KetamineDRUG

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.

ketamine group
SalineDRUG

0.9% saline solution

control group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33532995DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

KetamineSodium Chloride

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Jin Sun Cho, MD

CONTACT

82-2-2228-5448chjs0214@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 6, 2017

Study Start

September 1, 2017

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)