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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03273231
• Other study ID #: 4-2017-0475
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 2020

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Jin Sun Cho, MD
• Phone: 82-2-2228-5448
• Email: chjs0214[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patient between 20 and 80 of age with ASA physical status ?-?

• patient scheduled for laparoscopic colorectal cancer resection

Exclusion Criteria:

• ASA physical status ?

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• Saline
0.9% saline solution

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	natural killer cell cytotoxicity	Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).	Baseline
Primary	natural killer cell cytotoxicity	Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).	1 hour after surgery
Primary	natural killer cell cytotoxicity	Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).	postoperative day 1
Primary	natural killer cell cytotoxicity	Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).	postoperative day 2
Secondary	proinflammatory cytokine	Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.	Baseline
Secondary	proinflammatory cytokine	Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.	1 hour after surgery
Secondary	proinflammatory cytokine	Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.	postoperative day 1
Secondary	proinflammatory cytokine	Inflammtory response is assesssed by measuring levels of proinflammtory cytokines.	postoperative day 2
Secondary	recurrence	Cancer recurrence is evaluated 1 year after surgery.	1 year after surgery
Secondary	metastasis	Cancer metastasis is evaluated 1 year after surgery.	1 year after surgery