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AzTrials

Uterine CancerNCT02896413

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

A study testing Dexmedetomidine group in people with Uterine Cancer, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 70 years, women only
Conditions the study is for
Uterine Cancer
What is being tested?
Dexmedetomidine group
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteSouth Korea
Study dates
2 Jun 2016to 24 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul, 03722

Other trials in South Korea

About this study

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.

Conditions
Uterine Cancer
Being tested
Dexmedetomidine group, Control group
Medical subject headings
Uterine Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine groupDrug

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

  • Control groupDrug

    0.9% saline infusion

Study groups in NCT02896413
Study groupRoleWhat they receive
Dexmedetomidine GroupExperimentaldexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to 24 h after surgery
Receives: Drug: Dexmedetomidine group
Control GroupPlacebo comparator0.9% saline infusion
Receives: Drug: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. natural killer cell cytotoxicity

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

    Measured: 1 minute before surgery

  2. natural killer cell cytotoxicity

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

    Measured: postoperative day 1

  3. natural killer cell cytotoxicity

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

    Measured: postoperative day 3

  4. natural killer cell cytotoxicity

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

    Measured: postoperative day 5

Secondary outcomes (4)

  1. inflammatory response

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

    Measured: 1 minute before surgery

  2. inflammatory response

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

    Measured: postoperative day 1

  3. inflammatory response

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

    Measured: postoperative day 3

  4. inflammatory response

    inflammatory response is assessed by measuring levels of proinflammatory cytokines.

    Measured: postoperative day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2016 (estimated)
  2. Study start2 Jun 2016
  3. Primary completion24 Oct 2018
  4. Study completion24 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02896413
Sponsor's protocol ID
4-2015-0453
Status last verified
May 2021
First submitted
6 Sep 2016
Last updated
4 May 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine group in people with Uterine Cancer, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

natural killer cell cytotoxicity (time frame: 1 minute before surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02896413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.

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