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Patients undergoing gynecological surgery are at high risk of developing postoperative sleep disorders. Intraoperative opioid use is detrimental to the patient's postoperative recovery of gastrointestinal function. Esketamine has sedative, hypnotic, analgesic, inflammatory response suppression, and antidepressant effects. Its hypnotic mechanism may be related to its rapid blockade of NMDA receptors and hyperpolarization-activated cyclic nucleotide-gated cation channels. Also can reduce the application of perioperative opioids, which in turn promotes the recovery of gastrointestinal function in patients after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h | Experimental |
| |
| Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h | Experimental |
| |
| No esketamine | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esketamine | Drug | The corresponding esketamine dose for each group was used at the end of anesthesia induction, and esketamine was changed to the corresponding maintenance dose for each group prior to surgical skin incision. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the level of actigraphy | Through the actigraphy, monitor the patient's sleep quality. | Baseline (the night before surgery), postoperative nights 1 and 2 |
| Changes in the level of Pittsburgh sleep quality index | Assess the patient's sleep quality by asking questions on the scale on a scale of 0-21, with higher scores representing poorer sleep quality. | Baseline (the night before surgery), postoperative nights 1, 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the level of Mean Arterial Pressure | The outcome above should be measured at the time before induction, after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit. | Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit |
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Inclusion Criteria:
Exclusion Criteria:
(7)hearing or visual impairment that precludes a scale assessment.
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| Name | Affiliation | Role |
|---|---|---|
| zhuan zhang, professor | Yangzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Affiliated Hospital of Yangzhou University | Yangzhou | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41115350 | Derived | Yuan B, Tian S, Pu X, Yin J, Wang M, Feng S, Lv X, Sun Y, Yao H, Li M, Li S, Zhang Z. Esketamine improves postoperative sleep quality in women undergoing gynecological laparoscopy: A prospective, randomized, double-blind, and controlled trial. Sleep Med. 2025 Dec;136:106852. doi: 10.1016/j.sleep.2025.106852. Epub 2025 Oct 14. |
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| Changes in the level of IL-6 | The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day. | Preoperatively, upon surgery completion, postoperative day 1 |
| Changes in the level of Melatonin | The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day. | Preoperatively, upon surgery completion, postoperative day 1 |
| Changes in the level of BDNF | The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day. | Preoperatively, upon surgery completion, postoperative day 1 |
| Changes in the level of IL-10 | The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day. | Preoperatively, upon surgery completion, postoperative day 1 |
| Changes in the level of Heart Rate | The outcome above should be measured at the time before induction, after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit. | Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit |
| Changes in the level of Oxygen saturation | The outcome above should be measured at the time before induction, after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit. | Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit |
| Changes in the level of the visual analogue scale | Assess the patient's pain by asking on a scale of 0-10, with higher scores representing more severe pain. | Postoperative days 1 and 2 |
| Recovery of gastrointestinal function | Record the time of the first postoperative exhausting | Postoperative first 1 day |
| Recovery of gastrointestinal function | Record the time of the first postoperative bowel movement | Postoperative first 1 day |
| Recovery of gastrointestinal function | Record the time of the first postoperative feeding | Postoperative first 1 day |
| Postoperative adverse reactions | Record the occurrence of adverse reactions (nausea and vomiting, nightmares, dizziness, and mirages) on the 1st postoperative day. | Postoperative day 1 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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