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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Gastric Cancer, Gastrostomy

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (dexmedetomidine)<br>dexmedetomidine infusion group | Drug: dexmedetomidine<br>* Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.<br>|
| Placebo Comparator: Group B (saline)<br>normal saline infusion group | Drug: saline<br>* Saline infusion during same time period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Preoperative outpatient 1 day visit | 
| 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. | Immediately after surgery | 
| 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. | POD 1 day | 
| 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. | POD 2 day | 
| 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. | POD 3 day | 
| 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. | discharge day (Postoperative 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. | first visit after surgery (POD 1 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Preoperative outpatient visit) | 
| 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. | immediately after surgery (POD 0) | 
| 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. | POD 1 day | 
| 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. | POD 2 day | 
| 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. | POD 3 day | 
| 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. | discharge day (Postoperative 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. | first visit after surgery (POD 1 month) | 
| 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. | Baseline (Preoperative outpatient visit) | 
| 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. | immediately after surgery (POD 0) | 
| 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. | POD 1 day | 
| 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. | POD 2 day | 
| 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. | POD 3 day | 
| 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. | discharge day (Postoperative day 5) | 
| 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. | first visit after surgery (POD 1 month) | 
| 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. | postoperative 0 2hours | 
| 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. | 2 4 hours | 
| 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. | 4 8 hours | 
| 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. | 8 12 hours | 
| 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. | 12 24 hours | 
| 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. | 24 48 hours | 
| 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. | postoperative 1 month | 
| 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. | gas passing time immediately after surgery | 
| HOD (hospital days) | To evaluate the effect of dexmedetomidine on hospital day (HOD) in patients undergoing robot or laparoscopic gastrectomy, discharge day was checked. | total days from operation to discharge up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, laparoscopic gastrectomy, robotic gastrectomy