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Completed

NCT Number: NCT03960775

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrostomy Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Saline

Drug

Saline infusion during same time period.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 23, 2019
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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