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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (dexmedetomidine) | Experimental | dexmedetomidine infusion group |
|
| Group B (saline) | Placebo Comparator | normal saline infusion group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Na Young Kim, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine | Seoul | 03722 | South Korea |
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Double blind randomized controlled trial
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Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
| saline | Drug | Saline infusion during same time period. |
|
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) |
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 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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