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Although the acute and chronic postoperative pain of surgical patients has gradually been paid attention to, it has not yet been better resolved.and, the incidence of anxiety and depression in cancer patients is constantly increasing,The new analgesic anesthetic esketamine hydrochloride was launched in China last year,however, in the domestic and foreign literature, there are still few reports of esketamine hydrochloride in postoperative analgesia, and most of them are retrospective and small samples.This study aims to investigate whether esketamine has advantages over traditional opioids in terms of postoperative analgesia, anxiety and depression in cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose esketamine group | Experimental | After the operation, 5 mg esketamine was injected intravenously for postoperative analgesia. PCIA formula: hydromorphone 6mg + esketamine 45mg + tropisetron 10mg into 0.9% sodium chloride injection 100ml, the first dose is 20ug/kg , Background dose 2ug/kg/h, single dose 4ug/kg/time |
|
| Low-dose esketamine group | Experimental | After the operation, esketamine 2.5mg was injected intravenously for postoperative analgesia. PCIA formula: hydromorphone 6mg + esketamine 22.5mg + tropisetron 10mg into 0.9% sodium chloride injection 100ml, the first dose is 20ug/ kg, background dose 2ug/kg/h, single dose 4ug/kg/time |
|
| Control group | Placebo Comparator | PCIA formula: 6mg of hydromorphone + 10mg of tropisetron into 100ml of 0.9% sodium chloride injection, the first dose is 20ug/kg, the background dose is 2ug/kg/h, and the single dose is 4ug/kg/time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose Esketamine hydrochloride+Hydromorphone | Drug | By adding different doses of esketamine to the postoperative analgesic pump, and the control group without adding this drug to observe the postoperative pain, anxiety and depression indicators of the surgical patients |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of moderate to severe pain | Visual analog score is 4 points or more | Within 72 hours after surgery |
| Pain score | Visual analog scale | Within 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions | Nausea, vomiting, lethargy, mental symptoms, etc. | Within 72 hours after surgery |
| Postoperative analgesia | PCIA usage(ml), PCIA compressions(frequency), remedial analgesia measures(Name and dosage of intravenous analgesics) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Yan, Doctor | Zhejiang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University anesthesiology department | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Low-dose Esketamine hydrochloride+Hydromorphone | Drug | By adding different doses of esketamine to the postoperative analgesic pump, and the control group without adding this drug to observe the postoperative pain, anxiety and depression indicators of the surgical patients |
|
| Hydromorphone | Drug | No esketamine added |
|
| Within 48 hours after surgery |
| Sedation | Ramsay sedation score(The score is 1-6 points, the higher the score, the higher the degree of sedation, the ideal sedation score is 2 points) | Within 48 hours after surgery |
| Anxiety | Hamilton Anxiety Scale(There are a total of 14 options. Each item is divided into 0-4 points according to the degree, and the score is 0-56 points. The total score is ≥29 points, which may be severe anxiety; ≥21 points, there must be obvious anxiety; ≥14 points, there must be Anxiety; more than 7 points, there may be anxiety; if less than 7, there are no anxiety symptoms.) | Baseline (Before operation), 24 hours after operation, 72 hours after operation |
| Depression | Hamilton Depression Scale(There are a total of 17 options, and each item is divided into 0-4 points or 0-2 points according to the degree. The total score is less than 7 points: normal; the total score is 7~17 points: there may be depression; the total score is 17~24 points : There must be depression; total score> 24 points: severe depression) | Baseline (Before operation), 24 hours after operation, 72 hours after operation |
| Sleep condition | Sleep quality(Self-assessment by the patient, the score is 1-5 points, the higher the score, the better the sleep) | Within 72 hours after surgery |
| Chronic pain | Chronic pain conversion rate(Follow-up one month after surgery, if there are still pain symptoms, it is chronic pain) | One month after surgery |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |