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As a common problem observed in pediatric patients after sevoflurane anesthesia, emergence agitations are investigated mainly in children.For adults,previous studies were almost about the efficacy of premedication on preventing emergence agitation. Once emergence agitation happens, there is still no guidelines established to recommend the medication usage in the post-anaesthesia care unit.So high-quality prospective clinical studies are required to provide evidence for emergence agitation treatment.
Dexmedetomidine and propofol are both widely used in general anesthesia and can be acquired easily.When emergence agitation occurs,both injections are common choices in daily clinical administration on emergence agitation.To the investigator's knowledge ,propofol with a very quick onset is superior for anesthesia goals, but is without analgesia effects.While dexmedetomidine can produce sedation,analgesia,anxiolysis.So the investigators propose the hypothesis here that dexmedetomidine is prior to propofol on the treatment of emergence agitation in adults patients after general anesthesia.Therefore this research is undertaken to verify the hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine Group | Experimental | General anesthesia will be maintained by sevoflurane and remifentanil. End-tidal carbon dioxide will be controlled between 35 mmHg to 40 mmHg.Mean blood pressure(MAP) will be administrated between 80% and 120% of the baseline.Heart rate is going to be maintained between 50-100 beats per minute. In consultation with the surgeons and 5 minutes prior to the departure of the operating room,all the anesthesia agents are discontinued and the patient will be transferred to the post-anaesthesia care unit.And reversal agents are given to antagonize the residual muscular relaxant.Once emergence agitation occurs,the patient assigned to the dexmedetomidine group will be infused with a single dose of 0.7ug/kg dexmedetomidine. |
|
| Propofol Group | Active Comparator | General anesthesia will be maintained by sevoflurane and remifentanil. End-tidal carbon dioxide will be controlled between 35 mmHg to 40 mmHg.Mean blood pressure(MAP) will be administrated between 80% and 120% of the baseline.Heart rate is going to be maintained between 50-100 beats per minute. In consultation with the surgeons and 5 minutes prior to the departure of the operating room,all the anesthesia agents are discontinued and the patient will be transferred to the post-anaesthesia care unit.And reversal agents are given to antagonize the residual muscular relaxant.Once emergence agitation occurs,the patient assigned to the propofol group will be infused with a single dose of 0.5mg/kg propofol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | a selective Ī±-2 adrenoceptor agonist which is widely used as an adjuvant to general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group. |
| 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Riker Sedation-Agitation Scale scores before and after intervention; | Riker Sedation-Agitation Scale is raging from a maximum value of 7 to a minimum value of 1.Lower scores mean a better outcome. | 1 day |
| Heart rate before and after intervention; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Zhang, MD | Contact | 15150012530 | zhangsong1031@163.com | |
| Weifeng Yu, MD | Contact | 18918358260 | yuweifeng@renji.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital,Shanghai Jiao Tong University,School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34784941 | Derived | Feng Z, Shi X, Yan X, Zhu Y, Gu J, Zhu H, Yu W, Zhang S. Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial). Trials. 2021 Nov 16;22(1):811. doi: 10.1186/s13063-021-05743-2. |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Propofol | Drug | a short -acting medication that result in a decreased level of consciousness and lack of memory for events,widely used including the starting and maintenance of general anesthesia. |
|
Heart rate wil be recorded in beats per minute.
| 1 day |
| The consumption of sufentanil in the post-anaesthesia care unit; | During the procedure,a dose of 0.01ug/kg sulfentanil will be given when numeric rating scale scoresā„ 5 scores or the patient has a analgesia request; Numeric rating scale,with a maximum value of 10 and a minimum value of 0,is specifically as follows:0-3,slight pain;4-7,moderate pain;8-10,sever pain.Lower scores mean a better outcome. | 1 day |
| Nausea and vomiting scores when leaving the post-anesthesia care unit. | According the following scale with a maximum value of 3 and a minimum value of 0,is specifically as follows:0,no nausea;1,mild nausea;2,sever nausea requiring antiemetics;3,retching,vomiting or both.Lower scores mean a better outcome. | 1 day |
| Duration in the post-anaesthesia care unit | The total time from entering the post-anaesthesia care unit to leaving the post-anaesthesia care unit. | 1 day |
| Recovering quality: recovery scale | The recovering quality is evaluated by the 40-item quality of recovery scale,with a maximum value of 200 and a minimum value of 0.Higher scores mean a better outcome. | 24 hours after surgery. |
| Mean blood pressure before and after intervention; | Mean blood pressure will be recorded in millimeters of mercury. | 1 day |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |