NCT02896413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

2.4 years

First QC Date

September 6, 2016

Last Update Submit

May 3, 2021

Conditions

Uterine Cancer

Outcome Measures

Primary Outcomes (4)

  • natural killer cell cytotoxicity

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

    1 minute before surgery

  • natural killer cell cytotoxicity

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

    postoperative day 1

  • natural killer cell cytotoxicity

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

    postoperative day 3

  • natural killer cell cytotoxicity

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

    postoperative day 5

Secondary Outcomes (4)

  • inflammatory response

    1 minute before surgery

  • inflammatory response

    postoperative day 1

  • inflammatory response

    postoperative day 3

  • inflammatory response

    postoperative day 5

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

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

Drug: Dexmedetomidine group

Control Group

PLACEBO COMPARATOR

0.9% saline infusion

Drug: Control group

Interventions

Dexmedetomidine groupDRUG

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

Dexmedetomidine Group
Control groupDRUG

0.9% saline infusion

Control Group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 12, 2016

Study Start

June 2, 2016

Primary Completion

October 24, 2018

Study Completion

October 24, 2018

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)