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To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval
Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.
Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration. 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 surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance is worth exploring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group of patients undergoing oocyte retrieval with normal saline | Placebo Comparator | Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery |
|
| Group of patients undergoing oocyte retrieval with esketamine | Active Comparator | Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery |
|
| Group of patients undergoing oocyte retrieval with remimazolam | Active Comparator | Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal Saline | Drug | Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative sleep disturbance on the first night after surgery | Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first 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 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 one day before surgery | Patients completed the sleep quality scales(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 patients' preoperative 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 | Tianjin Medical University General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
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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 |
| C000629870 | Esketamine |
| C522201 | remimazolam |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Esketamine | Drug | Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery |
|
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| Remimazolam | Drug | Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery |
|
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| one day before surgery |
| The incidence of postoperative 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. | the second and third nights 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 and 2 days after surgery again to evaluate the changes in anxiety. We recorded HADS-A scores as statistical indicators. | 1 day before surgery ,1 and 2 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 and 2 days after surgery again to evaluate the changes in depression. We recorded HADS-D scores as statistical indicators. | 1 day before surgery ,1 and 2 days after surgery |
| Pain Score (NRS) | 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 and 2 days after surgery |
| Mean intraoperative blood pressure | The mean intraoperative blood pressure was recorded | Intraoperative |
| Oxygen saturation | The mean intraoperative oxygen saturation was recorded | Intraoperative |
| Somatokinetic reaction | The number of intraoperative body movements was recorded | Intraoperative |
| Operation time | The duration of the patient's operation was recorded(up to 24 h) | Intraoperative |
| Duration of anesthesia | The patient's duration of anesthesia was recorded(up to 24 h) | Intraoperative |
| Time to walking down | Record the time from waking up to walking down(up to 24 h) | Within1 hour after surgery |
| Adverse event | All kinds of adverse events(PONV、hypotension、hypertension,etc) occurred in patients were recorded | Within 3 days after surgery |