The Effects of Perioperative Dexmedetomidine Administration on Immune Suppression and Outcomes in Patients With Uterine Cancer Undergoing Radical Resection

Uterine Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896413
• Other study ID #: 4-2015-0453
• Status: Completed
• Phase: N/A
• Start date: June 2, 2016
• Est. completion date: October 24, 2018

Study information

• Verified date: May 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical stress and anesthesia may cause immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. Dexmedetomidine has sympatholytic effect and preserves NK cell function. This study investigate the effect of dexmedetomidine on immune suppression and postoperative outcomes in patients undergoing uterine cancer resection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• patient between 20 and 70 of age with ASA physical status ?-?

• patient scheduled for uterine cancer surgery

Exclusion Criteria:

• ASA physical status ?

• severe hepatorenal disease

• infection

• metastasis to other organ

• problem with communication

Related Conditions & MeSH terms

• Uterine Cancer
• Uterine Neoplasms

Intervention

Drug:
• Dexmedetomidine group
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to 24 h after surgery
• Control group
0.9% saline infusion

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy 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).	1 minute before 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 3
Primary	natural killer cell cytotoxicity	Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).	postoperative day 5
Secondary	inflammatory response	inflammatory response is assessed by measuring levels of proinflammatory cytokines.	1 minute before surgery
Secondary	inflammatory response	inflammatory response is assessed by measuring levels of proinflammatory cytokines.	postoperative day 1
Secondary	inflammatory response	inflammatory response is assessed by measuring levels of proinflammatory cytokines.	postoperative day 3
Secondary	inflammatory response	inflammatory response is assessed by measuring levels of proinflammatory cytokines.	postoperative day 5