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To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance
Sleep disturbance occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities. Women who requires surgical abortion due to fetal anomaly or unwanted pregnancy often experience sleep disturbance. Severe sleep disturbance is a strong indicator for postoperative sleep disorders, which can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative pain, and delay postoperative recovery.
Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgical abortion, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on sleep disturbance is worth exploring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group of patients undergoing surgical abortion with normal saline | Placebo Comparator | Patients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery |
|
| Group of patients undergoing surgical abortion with esketamine | Active Comparator | Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Drug | Patients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of sleep disturbance on the first night after surgery | Patients completed the sleep quality scale (AIS, Athens Insomnia Scale) on the first night after surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the first postoperative night to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators. | the first night after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of sleep disturbance on the second and third postoperative nights | Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the second and third day after surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the second and third postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guolin Wang, MD, PhD | Tianjin Medical University General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40804260 | Derived | Song Z, Miao M, Huang F, Hu L, Yang X, Cui W, Yu Y, Wang G, Wang C, Zhang L. Effect of a single low-dose esketamine administration during surgical abortion on postoperative sleep disturbance: a randomized controlled trial. Nat Commun. 2025 Aug 14;16(1):7533. doi: 10.1038/s41467-025-62933-1. |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| C000629870 | Esketamine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Esketamine | Drug | Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery |
|
|
| the second and third nights after surgery |
| The incidence of sleep disturbance on the seventh postoperative nights | Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the seventh day after surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the seventh postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators. | the seventh night after surgery |
| Postoperative anxiety | Patients completed the anxiety rating scales (HADS-A,Hospital Anxiety and Depression Scale-Anxiety subscale) on the day before surgery. HADS-A consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety. And we asked the patients to fill out this questionnaire on the 1, 2, 3 and 7 days after surgery again to evaluate the changes in anxiety. We recorded HADS-A scores as statistical indicators. | 1 day before surgery, 1, 2, 3 and 7 days after surgery |
| Postoperative depression | Patients completed the depression rating scales (HADS-D,Hospital Anxiety and Depression Scale-Depression subscale) on the day before surgery. HADS-D consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression. And we asked the patients to fill out this questionnaire on the 1, 2, 3 and 7 days after surgery again to evaluate the changes in depression. We recorded HADS-D scores as statistical indicators. | 1 day before surgery, 1, 2, 3 and 7 days after surgery |
| Pain intensity | The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain. | 1 hour after surgery, 1, 2, 3 and 7 days after surgery |
| Adverse event | All kinds of adverse events (nausea, vomiting, tachycardia, hypertension, somnolence, dizziness, hallucination, diplopia, etc) occurred in patients were recorded | Within 1 hour after surgery, within 1 day after surgery |
| preoperative hemoglobin concentration | Hemoglobin concentration in venous blood was measured. | the day before surgery |
| Human Chorionic Gonadotropin level | Human Chorionic Gonadotropin (HCG) in venous blood was measured. | within one week before surgery, within one week after surgery |
| The incidence of sleep disturbance on the day before surgery | Patients completed the sleep quality scale (AIS, Athens Insomnia Scale) on the day before surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire on the day before surgery to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators. | the day before surgery |
| The incidence of sleep disturbance before surgery | Patients completed the sleep quality scale (PSQI, Pittsburgh sleep quality index) on the day before surgery. The PSQI has a total of 24 items(Including 19 self-evaluation items and 5 other evaluation items),of which the 19th self-evaluation item and 5 other self-evaluation items do not participate in scoring, while the remaining 18 self-evaluation items participate in scoring, with each item scoring 0-3 points. The total score of the scale ranges from 0 to 21 points, with a total score higher than 5 indicating poor sleep quality. We require patients to fill out this questionnaire one day before surgery to evaluate whether they have had sleep disorders in the past month.We recorded PSQI scores as statistical indicators. | the day before surgery |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |