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The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are:
Does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better? The researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine group | Experimental | Intraoperative infusion of 0.3ug/kg/h dexmedetomidine |
|
| esketamine group | Experimental | Intraoperative infusion of 0.3mg/kg/h esketamine |
|
| control group | Placebo Comparator | Intraoperative infusion of equal volumes of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative infusion of dexmedetomidine | Drug | Intraoperative infusion of 0.3ug/kg/h dexmedetomidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device | 1, 3, 7days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | Assessment of postoperative pain levels by Visual Analogue Scale(VAS),from 0 to 10, Higher scores mean more severe pain,VAS>4 means positive. | 24 hours and 48 hours after surgery |
| Record postoperative analgesic medications used and the amount used for postoperative pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuang xueyi | Contact | 86+18651908072 | kxy809707496@126.com | |
| hongwei shi | Contact | 86+18951670892 | mdshw@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital,Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210006 | China |
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| Intraoperative infusion of esketamine | Drug | Intraoperative infusion of 0.3mg/kg/h esketamine |
|
| Saline control | Drug | Intraoperative infusion of equal volumes of saline |
|
Record postoperative analgesic medications used and the amount used |
| 24 hours and 48 hours after surgery |
| anxiety and depression assessment | Assessment of anxiety and depression levels by Hospital anxiety and depression scale (HADS),0-7 is negative; 8-10 is mild; 11-14 is moderate; 15-21 is severe. | 1,3 days after surgery |
| Postoperative complications | including nausea and vomiting, dizziness, itching, nightmares and so on. | 48 hours after surgery |
| Postoperative delirium | Assessment of Postoperative delirium by Confusion Assessment Method (CAM),scores > 21 is positive. | from 1 day to 7 days after surgery |
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210006 | China |
|
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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