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Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Preemptive analgesia of dexmedetomidine (DEX) in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation.
Objective: To investigate the per-operative effects of DEX preemptive analgesia.
Method:The patients scheduled noncardiac surgery undergoing general anesthesia were selected and divided into DEX group and Placebo group randmized. The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and 15min after induction. The Placebo group was infused with equal amounts of normal saline.The Coprimary efficacy outcome was a composite of analgesia effect, one is the Compliance Rate of IOC2 target in intra-operation, another is the the rate of none-to-slight post-operative pain assessed with the p-NRS≦3 at 12 hours after surgery [Pain numeric rating scale was assessed with the (Numeric Rating Scale, p-NRS)].
Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Preemptive analgesia of DEX in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation.
Objective: To investigate the per-operative effects of DEX preemptive analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and after induction continue infusion 15min. |
|
| Placebo group | Placebo Comparator | the Placebo group was infused with equal amounts of 0.9% Sodium Chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preemptive Dexmedetomidine injection | Drug | The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and after induction continue infusion 15min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The coprimary efficacy outcome | The rate of intro-operative IOC2 target reachment | During the whole operation |
| The coprimary efficacy outcome | The rate of none-to-slight post-operative pain, assessed with the (Numeric Rating Scale)p-NRS< =3 at 24h post-opertively. | post-operative 24 hours |
| The primary safety outcome | Adverse events and safety outcomes within during 48 h post-operation: hypotension, Hypertension,Bradycardia,Tachycardia,Respiratory depression,Pulse oxygen desaturation and the number of patients which need intervention. | During 48 h post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| SBP | systolic blood pressure(intraoperative hemodynamics) | During the whole operation |
| DBP | dystolic blood pressure(intraoperative hemodynamics) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanghai Cui, prof | Contact | +861083199270 | +8618196987786 | 1055885750@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu hospital | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42207991 | Derived | Wang X, Chang H, Qi W, Wang H, Huang Y, Wu Z, Wang Q, Jiang W, Wang T. Dexmedetomidine Preemptive Analgesia on Intra- and Postoperative Pain in Noncardiac Surgery: A Randomized, Double-Blind, Controlled Study. Anesth Analg. 2026 May 28. doi: 10.1213/ANE.0000000000008078. Online ahead of print. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Sodium Chloride 0.9% Inj | Drug | The Placebo group was infused with equal amounts of isochronous normal saline. |
|
|
| During the whole operation |
| MAP | mean arterial pressure(intraoperative hemodynamics) | During the whole operation |
| HR | Heart rate (intraoperative hemodynamics) | During the whole operation |
| Bispectral index | Bispectral index | During the whole operation |
| EMG | Electromyogram Index | During the whole operation |
| pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively | Record and compared the pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively. (The p-NRS was an 11-point scale with 0 indicating no pain and 10 equaled worst pain). | post-operation p-NRS until 7 days(inculde Hour 0, Hour 24, Hour 48, and the Day 7 timepoints) |
| mPONV | modified postoperative nausea vomiting (mPONV) score at postoperative immediately (0 hour)and 24 hours post-operatively. Modified PONV Scoring Criteria: 0 points: No nausea or vomiting.
| Postoperative immediately and until 12 hours post-operatively |
| The accumulation of analgesia consumption | The accumulation of analgesia consumption was used to describe oxycodone accumulation (oral administration of oxycodone 5 mg for each complaint of pain) at Hour 24, Hour 48, and the Day 7 after surgery. | Hour 24, Hour 48, and the Day 7 after surgery |
| Dizziness | Dizziness at Hour 0, Hour 24 and the Hour 48 post-operatively | Hour 0, Hour 24 and the Hour 48 post-operatively |
| Agitation | Agitation immediately afer surgery(Hour 0 post-operation) | immediately afer surgery(Hour 0 post-operation) |
| The rate of exhaust | The rate of exhaust at first 24hours post-operation | until 24hours post-operation |
| Extubation time | Extubation time | after operation immediately |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |