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OpenTrials
Completed

NCT Number: NCT02896413

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

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.

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Key information

Conditions

Uterine Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
  • patient scheduled for uterine cancer surgery

Exclusion criteria

  • ASA physical status Ⅳ
  • severe hepatorenal disease
  • infection
  • metastasis to other organ
  • problem with communication

Treatment and study plan

dexmedetomidine group

Drug

dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to 24 h after surgery

Control group

Drug

0.9% saline infusion

Primary outcomes

  1. natural killer cell cytotoxicity

    Time frame: 1 minute before surgery

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

  2. natural killer cell cytotoxicity

    Time frame: postoperative day 1

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

  3. natural killer cell cytotoxicity

    Time frame: postoperative day 3

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

  4. natural killer cell cytotoxicity

    Time frame: postoperative day 5

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

Secondary outcomes

  1. inflammatory response

    Time frame: 1 minute before surgery

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

  2. inflammatory response

    Time frame: postoperative day 1

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

  3. inflammatory response

    Time frame: postoperative day 3

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

  4. inflammatory response

    Time frame: postoperative day 5

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2016
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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