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

Primary Purpose

Uterine Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine group
Control group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Uterine Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine Group

Control Group

Arm Description

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

0.9% saline infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

inflammatory response
inflammatory response is assessed by measuring levels of proinflammatory cytokines.
inflammatory response
inflammatory response is assessed by measuring levels of proinflammatory cytokines.
inflammatory response
inflammatory response is assessed by measuring levels of proinflammatory cytokines.
inflammatory response
inflammatory response is assessed by measuring levels of proinflammatory cytokines.

Full Information

First Posted
September 6, 2016
Last Updated
May 3, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02896413
Brief Title
The Effects of Perioperative Dexmedetomidine Administration on Immune Suppression and Outcomes in Patients With Uterine Cancer Undergoing Radical Resection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine Group
Arm Type
Experimental
Arm Description
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to 24 h after surgery
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
0.9% saline infusion
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine group
Intervention Description
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to 24 h after surgery
Intervention Type
Drug
Intervention Name(s)
Control group
Intervention Description
0.9% saline infusion
Primary Outcome Measure Information:
Title
natural killer cell cytotoxicity
Description
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Time Frame
1 minute before surgery
Title
natural killer cell cytotoxicity
Description
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Time Frame
postoperative day 1
Title
natural killer cell cytotoxicity
Description
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Time Frame
postoperative day 3
Title
natural killer cell cytotoxicity
Description
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Time Frame
postoperative day 5
Secondary Outcome Measure Information:
Title
inflammatory response
Description
inflammatory response is assessed by measuring levels of proinflammatory cytokines.
Time Frame
1 minute before surgery
Title
inflammatory response
Description
inflammatory response is assessed by measuring levels of proinflammatory cytokines.
Time Frame
postoperative day 1
Title
inflammatory response
Description
inflammatory response is assessed by measuring levels of proinflammatory cytokines.
Time Frame
postoperative day 3
Title
inflammatory response
Description
inflammatory response is assessed by measuring levels of proinflammatory cytokines.
Time Frame
postoperative day 5

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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