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CompletedNCT03960775Updated Sep 28, 2020

The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy

An interventional study of dexmedetomidine and saline in Gastric Cancer and Gastrostomy, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-28.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

Many studies have shown that inflammation has an important effect on the development, progression, and also response to treatment of tumors. Dexmedetomidine is a potent and selective alpha 2 receptor agonist, known to have a sedative, analgesic and immune-controlling effect. The purpose of this study is to investigate the effect of dexmedetomidine during surgery on postoperative inflammatory response and surgical recovery in gastric cancer patients undergoing robot or laparoscopic gastrectomy.

Read the detailed description
  • Experimental group (Dexmedetomidine group) Continuous IV Precedex™ using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery (from immediately after induction to before starting peritoneum closure) Infusion rate 0.4μg/kg/hr
  • Control group (normal saline group) Continuous IV normal saline using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery Infusion rate 0.4μg/kg/hr
02

Conditions studied

  • Gastric Cancer
  • Gastrostomy

Keywords

  • gastric cancer
  • laparoscopic gastrectomy
  • robotic gastrectomy
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 84 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. 20-70 yrs old patients
    1. Scheduled for robot or laparoscopic gastrectomy
    1. Body weight under 90kg and BMI under 32

Exclusion criteria

Exclusion Criteria:

    1. Emergency operation
    1. Reoperation
    1. Co-operation with other surgery department
    1. Co-operation with other organs (except cholecystectomy)
    1. Patients with history of heart failure (unstable angina, congestive heart failure)
    1. Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem
    1. Patients with history of uncontrolled hypertension (diastolic BP >110mmHg), extremely bradycardia (HR \<45 bpm on ECG)
    1. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia
    1. Patients who is steroid user
    1. Patients who is beta blocker user
    1. Patients with history of liver failure, renal failure, allergic to medicine
    1. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
    1. Patients who cannot read the consent form (examples: Illiterate, foreigner)
    1. Patients who withdraw the consent
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Group A (dexmedetomidine)

    dexmedetomidine infusion group

    Drug: dexmedetomidine

  • Placebo comparator
    Group B (saline)

    normal saline infusion group

    Drug: saline

Interventions

  • Drugdexmedetomidine

    Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.

  • Drugsaline

    Saline infusion during same time period.

06

What researchers measure

Primary outcomes

  1. CRP level in blood

    To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

    Time frame: Preoperative outpatient 1 day visit

  2. CRP level in blood

    To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

    Time frame: Immediately after surgery

  3. CRP level in blood

    To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

    Time frame: POD 1 day

  4. CRP level in blood

    To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

    Time frame: POD 2 day

  5. CRP level in blood

    To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

    Time frame: POD 3 day

  6. CRP level in blood

    To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

    Time frame: discharge day (Postoperative day 5)

  7. CRP level in blood

    To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

    Time frame: first visit after surgery (POD 1 month)

Secondary outcomes

  1. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

    To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

    Time frame: Baseline (Preoperative outpatient visit)

  2. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

    To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

    Time frame: immediately after surgery (POD 0)

  3. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

    To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

    Time frame: POD 1 day

  4. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

    To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

    Time frame: POD 2 day

  5. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

    To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

    Time frame: POD 3 day

  6. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

    To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

    Time frame: discharge day (Postoperative day 5)

  7. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

    To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

    Time frame: first visit after surgery (POD 1 month)

  8. WBC level

    To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.

    Time frame: Baseline (Preoperative outpatient visit)

  9. WBC level

    To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.

    Time frame: immediately after surgery (POD 0)

  10. WBC level

    To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.

    Time frame: POD 1 day

  11. WBC level

    To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.

    Time frame: POD 2 day

  12. WBC level

    To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.

    Time frame: POD 3 day

  13. WBC level

    To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.

    Time frame: discharge day (Postoperative day 5)

  14. WBC level

    To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.

    Time frame: first visit after surgery (POD 1 month)

  15. postoperative pain score (NRS 0~10)

    To evaluate the effect of dexmedetomidine on score of postoperative pain in patients undergoing robot or laparoscopic gastrectomy, NRS was measured during postoperative 48 hours.

    Time frame: postoperative 0~2hours

  16. postoperative pain score (NRS 0~10)

    To evaluate the effect of dexmedetomidine on score of postoperative pain in patients undergoing robot or laparoscopic gastrectomy, NRS was measured during postoperative 48 hours.

    Time frame: 2~4 hours

  17. postoperative pain score (NRS 0~10)

    To evaluate the effect of dexmedetomidine on score of postoperative pain in patients undergoing robot or laparoscopic gastrectomy, NRS was measured during postoperative 48 hours.

    Time frame: 4~8 hours

  18. postoperative pain score (NRS 0~10)

    To evaluate the effect of dexmedetomidine on score of postoperative pain in patients undergoing robot or laparoscopic gastrectomy, NRS was measured during postoperative 48 hours.

    Time frame: 8~12 hours

  19. postoperative pain score (NRS 0~10)

    To evaluate the effect of dexmedetomidine on score of postoperative pain in patients undergoing robot or laparoscopic gastrectomy, NRS was measured during postoperative 48 hours.

    Time frame: 12~24 hours

  20. postoperative pain score (NRS 0~10)

    To evaluate the effect of dexmedetomidine on score of postoperative pain in patients undergoing robot or laparoscopic gastrectomy, NRS was measured during postoperative 48 hours.

    Time frame: 24~48 hours

  21. postoperative any unwanted admission

    To evaluate the effect of dexmedetomidine on postoperative any unwanted admission in patients undergoing robot or laparoscopic gastrectomy, postoperative any unwanted admission was checked during postoperative 1 month.

    Time frame: postoperative 1 month

  22. gas passing out time

    To evaluate the effect of dexmedetomidine on gas passing in patients undergoing robot or laparoscopic gastrectomy, gas passing out time was checked.

    Time frame: gas passing time immediately after surgery

  23. HOD (hospital days)

    To evaluate the effect of dexmedetomidine on hospital day (HOD) in patients undergoing robot or laparoscopic gastrectomy, discharge day was checked.

    Time frame: total days from operation to discharge up to 2 weeks

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
    Seoul, 03722, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03960775
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
May 23, 2019
Start date
Apr 30, 2019
Primary completion
Nov 29, 2019
Completion
Nov 29, 2019
Last update
Sep 28, 2020

Study contacts

Na Young Kim, MD
principal investigator · Severance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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