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The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esketamine | Experimental | Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 . |
|
| saline | Placebo Comparator | Saline will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine | Drug | Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery . |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery | It will be evaluated by Athens Insomnia Scale (AIS) on the morning(8-10 am) of postoperative days 1-3, a score of 6 or higher will be defined as PSD. | during the first three days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment. | It will be evaluated by an sleep monitoring equipment which can record total sleep time in hour. | on the postoperative day 1 and postoperative day 3 after surgery |
| The pain scores |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of all drug-related adverse events | All drug-related adverse events including bradycardia, hypotension, tachycardia, hypertension, arrhythmia, nystagmus, hypersalivation, euphoria, emergence agitation, hallucinations, dreaminess and nightmares during surgery or before discharge.etc.Patients will be followed up for 3 days consecutively(at 8-10am). | within 72hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tian Tan Hospital | Recruiting | Beijing | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40037679 | Derived | Jian M, Chen Y, Wang S, Zhou Y, Liu H, Liang F, Han R, Wang H. Effect of esketamine on postoperative sleep disturbance in patients undergoing spinal surgery: a study protocol for a randomised, double-blinded, placebo-controlled clinical trial. BMJ Open. 2025 Mar 4;15(3):e090089. doi: 10.1136/bmjopen-2024-090089. |
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All data generated or analysed during this study will be included in published article. The data that support the findings of this study are available from the corresponding author, HW upon reasonable request.
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The data that support the findings of this study are available from the corresponding author, HW upon reasonable request.
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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 |
|---|---|
| C000629870 | Esketamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| saline | Drug | Saline will be infused at a speed of 0.3mg / kg / h during surgery . |
|
Postoperative pain at rest and movement will be evaluated on the morning(8-10 am) of postoperative days 1-3 using NRS.0 indicating no pain, 10 indicating worst pain imaginable. |
| within 72hours after surgery |
| dosage of analgesics | The analgesic consumption(PCIA) and supplemental analgesics within 72h will be recorded. | within 72 hours after surgery |
| Postoperative hospital anxiety and depression scale ( HADS ) score. | Postoperative anxiety and depression scores will be measured by the Hospital Anxiety and Depression Scale, on the morning(8-10 am) of postoperative days (PODs) 1 and 3 , a score of 8 points or higher will be diagnosed as depression or anxiety. | on the postoperative day 1 and postoperative day 3 after surgery |
| D017670 |
| Sodium Compounds |