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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02896413
Other study ID # 4-2015-0453
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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