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Dexmedetomidine is a highly selective alpha2-adrenergic receptor agonist with sedative, analgesic, anti-anxiety, and inhibitory sympathetic nerve excitation properties. It is commonly used in clinical anesthesia and intensive care.Radical gastrectomy for gastrointestinal malignant tumors is a common major operation in clinical practice, with long operation time, great trauma and strong stress response of patients. Dexmedetomidine is often used in general anesthesia during such operations, but its long-term use or large dose may produce certain side effects.Common side effects of dexmedetomidine include bradycardia and hypotension, etc. Previous studies have reported that dexmedetomidine can prolong QT interval and is at risk of causing tip torsion type ventricular tachycardia.Abnormal Potassium may affect myocardial repolarization and increase the risk of tip torsion ventricular tachycardia.The main purpose of this study was to observe the effects of long-term use of dexmedetomidine on perioperative internal environment such as electrolyte and rehabilitation indicators during radical general anesthesia for gastrointestinal malignancy, and the secondary purpose was to explore the optimal dose of dexmedetomidine for general anesthesia for patients undergoing radical general anesthesia for gastrointestinal malignancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control with normal saline | Placebo Comparator |
| |
| dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.25 µg/kg/h | Experimental |
| |
| dexmedetomidine loading dose 0.5 µg/kg + maintenance dose 0.5 µg/kg/h | Experimental |
| |
| dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.5 µg/kg/h | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | The loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrolyte and quality of recovery of the patients |
| Measure | Description | Time Frame |
|---|---|---|
| age | the age(years) | perioperative |
| weight | weight(kg) | perioperative |
| height | height(m) | perioperative |
| sex | sex(male/female) | perioperative |
| ASA status | ASA status of patients | perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| internal environment | the concentrations of sodium(mmol/L), lactate(mmol/L), potassium(mmol/L), calcium(mmol/L), base excess(mmol/L), base excess in the extracellular fluid compartment(mmol/L) were measured before the dexmedetomidine infusion (t1), 1 h after the surgery began (t2), at the end of the surgery (t3), and 1 h after transfer to the PACU (t4), 24h after the surgery | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| drugs | the dosage of propofol, remifentanil and ephedrine | 1 day |
| blood pressure | records the systolic blood pressure(mmHg), diastolic blood pressure(mmHg), and mean blood pressure(mmHg) of preoperative (T1), after infusion of loading dose of dexmedetomidine (T2), operation start (T3), operation start 5 min (T4), operation start 10 min (T5), operation start 1 h (T6), operation end(T7), immediately after extubation (T8), 5 min after extubation (T9) and into PACU 30 minutes (T10) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Affiliated Hospital of Yangzhou University | Yangzhou | Jiangsu | 225012 | China |
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| Dexmedetomidine | Drug | The loading dose with 1.0 μg/kg, maintenance dose with 0.25 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology and quality of recovery of the patient |
|
| Dexmedetomidine | Drug | The loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology and quality of recovery of the patients |
|
| Normal saline | Drug | Normal saline is used to observe the effect on the electrophysiology and quality of recovery of the patients |
|
| into PACU 30 minutes |
| heart rate | records the heart rate(beats/minute) of preoperative (T1), after infusion of loading dose of dexmedetomidine (T2), operation start (T3), operation start 5 min (T4), operation start 10 min (T5), operation start 1 h (T6), operation end(T7), immediately after extubation (T8), 5 min after extubation (T9) and into PACU 30 minutes (T10) | into PACU 30 minutes |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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