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Using random case assignment to investigate the analgesic and sedative effect of intravenous dexmedetomidine and dexmedetomidine as a local anesthetic adjuvant in ultrasound-guided subcostal TAP block in gastric cancer patient undergoing gastrectomy or partial gastrectomy.
The process of the experiment (brief describe) The participant patients will be randomly allocated into three groups: the intravenous dexmedetomidine group (Dex_iv group), dexmedetomidine adding to local anesthetic as an adjuvant for subcostal TAP block (Dex_adj group), and Control group. All patients receive gastrectomy or partial gastrectomy in general anesthesia as standard. Thirty minutes before the end of surgery, the patients in Dex_iv group receive 0.5mcg/kg dexmedetomidine infusion for 30 minutes, while the patients in Dex_adj group and control group receive 0.125ml/kg 0.9% normal saline IV infusion for 30 minutes. All patients have ultrasound-guided TAP block single injection after the end of surgery and before the tracheal tube extubation. The block agents in Dex_adj group is 40 ml of 0.375% ropivacaine with 0.5mcg/kg dexmedetomidine, while in Dex_iv group and control group are only 40ml of 0.375% ropivacaine. The IV PCA pump will be set up before patients awaken in the post-anesthesia care unit. All patients are assessed for the signs of emergence agitation with Riker sedation-agitation scale in the post-anesthesia care unit. The numerical rating scale (NRS) for pain intensity assessment, the opioid consumption via IV PCA pump, and the patients satisfaction will be documented for postoperative 3 days for the impact evaluation of dexmedetomidine in postoperative analgesia in patients undergoing gastric cancer surgery with subcostal TAP block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine_iv group | Experimental | Dexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min |
|
| Dexmedetomidine_adj group | Experimental | Dexmedetomidine 0.5mcg/kg (adding to local anesthetic) perineural single bolus for subcostal TAP block 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min |
|
| Control group | Active Comparator | 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block |
|
| Measure | Description | Time Frame |
|---|---|---|
| analgesic effect - pain intensity | postoperative acute pain intensity (numerical rating scale, NRS, 0-10) | postoperative 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| sedative effect | emergence agitation in post-anesthesia care unit (Riker sedation-agitation scale, 1-7) | postoperative 2 hours |
| analgesic effect - opioid consumption | Fentanyl consumption(mcg) via patient-control analgesia (PCA) pump |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miao-Pei Su, M.D. | Contact | 0088673121101 | 7033 | cavia0803@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Miao-Pei Su, M.D. | Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | Taiwan |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
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|
| 0.9% Sodium-chloride | Drug | 0.125ml/kg intravenously infusion in Dexmedetomidine_adj group and control group |
|
| postoperative 3 days |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |