An Early Phase 1 interventional study of Dexmedetomidine and Propofol in Emergence Agitation, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by RenJi Hospital · Early Phase 1, Interventional, and Treatment
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.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's planned enrollment of 120 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
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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.
Drug: Dexmedetomidine
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.
Drug: Propofol
a selective α-2 adrenoceptor agonist which is widely used as an adjuvant to general anesthesia
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.
The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group.
1. The Riker Sedation-Agitation Scale is raging from a maximum value of 7 to a minimum value of 1.Lower scores mean a better outcome. 2. A Riker Sedation-Agitation scale score of 5 or more than 5 will be considered as emergence agitation.
Time frame: 1 day
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.
Time frame: 1 day
Heart rate before and after intervention;
Heart rate wil be recorded in beats per minute.
Time frame: 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 scores≥ 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after surgery.
Mean blood pressure before and after intervention;
Mean blood pressure will be recorded in millimeters of mercury.
Time frame: 1 day
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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RenJi Hospital