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Trial record 3 of 6 for:    "Gastric Cancer" | "Dexmedetomidine"

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

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ClinicalTrials.gov Identifier: NCT03960775
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastrostomy Drug: dexmedetomidine Drug: saline Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
Primary Purpose: Supportive Care
Official Title: The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy; Double Blind Randomized Controlled Trial
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A (dexmedetomidine)
dexmedetomidine infusion group
Drug: dexmedetomidine
Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.

Placebo Comparator: Group B (saline)
normal saline infusion group
Drug: saline
Saline infusion during same time period.




Primary Outcome Measures :
  1. CRP level in blood [ Time Frame: Preoperative outpatient 1 day visit ]
    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.

  2. CRP level in blood [ Time Frame: Immediately after surgery ]
    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.

  3. CRP level in blood [ Time Frame: POD 1 day ]
    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.

  4. CRP level in blood [ Time Frame: POD 2 day ]
    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.

  5. CRP level in blood [ Time Frame: POD 3 day ]
    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.

  6. CRP level in blood [ Time Frame: discharge day (Postoperative day 5) ]
    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.

  7. CRP level in blood [ Time Frame: first visit after surgery (POD 1 month) ]
    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.


Secondary Outcome Measures :
  1. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [ Time Frame: Baseline (Preoperative outpatient visit) ]
    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.

  2. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [ Time Frame: immediately after surgery (POD 0) ]
    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.

  3. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [ Time Frame: POD 1 day ]
    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.

  4. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [ Time Frame: POD 2 day ]
    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.

  5. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [ Time Frame: POD 3 day ]
    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.

  6. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [ Time Frame: discharge day (Postoperative day 5) ]
    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.

  7. cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [ Time Frame: first visit after surgery (POD 1 month) ]
    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.

  8. WBC level [ Time Frame: Baseline (Preoperative outpatient visit) ]
    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.

  9. WBC level [ Time Frame: immediately after surgery (POD 0) ]
    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.

  10. WBC level [ Time Frame: POD 1 day ]
    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.

  11. WBC level [ Time Frame: POD 2 day ]
    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.

  12. WBC level [ Time Frame: POD 3 day ]
    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.

  13. WBC level [ Time Frame: discharge day (Postoperative day 5) ]
    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.

  14. WBC level [ Time Frame: first visit after surgery (POD 1 month) ]
    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.

  15. postoperative pain score (NRS 0~10) [ Time Frame: postoperative 0~2hours ]
    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.

  16. postoperative pain score (NRS 0~10) [ Time Frame: 2~4 hours ]
    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.

  17. postoperative pain score (NRS 0~10) [ Time Frame: 4~8 hours ]
    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.

  18. postoperative pain score (NRS 0~10) [ Time Frame: 8~12 hours ]
    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.

  19. postoperative pain score (NRS 0~10) [ Time Frame: 12~24 hours ]
    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.

  20. postoperative pain score (NRS 0~10) [ Time Frame: 24~48 hours ]
    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.

  21. postoperative any unwanted admission [ Time Frame: postoperative 1 month ]
    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.

  22. gas passing out time [ Time Frame: gas passing time immediately after surgery ]
    To evaluate the effect of dexmedetomidine on gas passing in patients undergoing robot or laparoscopic gastrectomy, gas passing out time was checked.

  23. HOD (hospital days) [ Time Frame: total days from operation to discharge up to 2 weeks ]
    To evaluate the effect of dexmedetomidine on hospital day (HOD) in patients undergoing robot or laparoscopic gastrectomy, discharge day was checked.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960775


Contacts
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Contact: Na Young Kim, MD 82-10-8871-2786 knnyyy@yuhs.ac

Locations
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Korea, Republic of
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

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03960775     History of Changes
Other Study ID Numbers: 4-2019-0055
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:
gastric cancer
laparoscopic gastrectomy
robotic gastrectomy

Additional relevant MeSH terms:
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Stomach Neoplasms
Dexmedetomidine
Inflammation
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action