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This national, multi-center, randomized controlled study, through the study of intravenous injection of estaketamine in elderly patients undergoing surgery, is expected to explore whether estaketamine can improve the acute postoperative pain of elderly patients undergoing surgery and reduce the incidence of postoperative depression and delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group (esketamine injection) | Experimental | Test group (esketamine injection group)： Intravenous infusion of esketamine: after induction, a single dose of 0.25 mg/kg before skin incision，and continuous 0.125 mg/kg/h until 30 min before surgery was stopped. |
|
| Control group (placebo: saline) | Placebo Comparator | Control group (placebo: saline): after induction, a single intravenous infusion of an equal amount of 0.9% saline before skin incision, followed by a continuous infusion at the same rate as the test group until 30 min before surgery was stopped. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine hydrochloride | Drug | Intravenous infusion of esketamine: after induction, a single dose of 0.25 mg/kg before skin incision，and continuous 0.125 mg/kg/h until 30 min before surgery was stopped. |
| Measure | Description | Time Frame |
|---|---|---|
| NRS pain score at the 24th hour after operation. | NRS pain score at the 24th hour after operation. | 24th hour after operation |
| Measure | Description | Time Frame |
|---|---|---|
| NRS pain scores at the 2nd hour, 48th hour and 72nd hour after operation. | NRS pain scores at the 2nd hour, 48th hour and 72nd hour after operation. | the 2nd hour, 48th hour and 72nd hour after operation. |
| The evaluation of APS-POQ-R questionnaire at 24 hours, 48 hours and 72 hours after operation. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoying Zhang | Contact | +8613021919086 | zxystudy@163.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | after induction, a single intravenous infusion of an equal amount of 0.9% saline before skin incision, followed by a continuous infusion at the same rate as the test group until 30 min before surgical cessation. |
|
The evaluation of APS-POQ-R questionnaire at 24 hours, 48 hours and 72 hours after operation. |
| 24 hours, 48 hours and 72 hours after operation. |
| The consumption of anesthetic and analgesic drugs during and within 72 hours after operation. | during and within 72 hours after operation. |
| The scores of Montgomery Depression Scale at 24th hour, 48th hour and 72nd hour after operation. | 24th hour, 48th hour and 72nd hour after operation. |
| The score of GAD-7 anxiety scale 72 hours after operation. The incidence of delirium within 72 hours after operation | 72 hours after operation |
| The incidence of delirium within 72 hours after operation | 72 hours after operation |
| The incidence of adverse events during and within 72 hours after operation. | 72 hours after operation. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D017670 |
| Sodium Compounds |