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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02896413
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
28.7
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine group
  • Drug: Control group
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Other
Actual Study Start Date :
Jun 2, 2016
Actual Primary Completion Date :
Oct 24, 2018
Actual Study Completion Date :
Oct 24, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexmedetomidine Group

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

Drug: Dexmedetomidine group
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to 24 h after surgery
Placebo Comparator: Control Group

0.9% saline infusion

Drug: Control group
0.9% saline infusion

Outcome Measures

Primary Outcome Measures

  1. natural killer cell cytotoxicity [1 minute before surgery]

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

  2. natural killer cell cytotoxicity [postoperative day 1]

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

  3. natural killer cell cytotoxicity [postoperative day 3]

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

  4. natural killer cell cytotoxicity [postoperative day 5]

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

Secondary Outcome Measures

  1. inflammatory response [1 minute before surgery]

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

  2. inflammatory response [postoperative day 1]

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

  3. inflammatory response [postoperative day 3]

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

  4. inflammatory response [postoperative day 5]

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Seoul Korea, Republic of 03722

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT02896413
Other Study ID Numbers:
  • 4-2015-0453
First Posted:
Sep 12, 2016
Last Update Posted:
May 4, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Uterine Neoplasms
Dexmedetomidine

Study Results

No Results Posted as of May 4, 2021