Comparing the Efficacy of Dexmedetomidine and Propofol in the Treatment of Emergence Agitation Occurring in Adults After General Anesthesia: A Randomised Control Trial DP-TEA Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group.
研究概览
简要总结
- This clinical research aims to compare the effects of dexmedetomidine and propofol on the treatment of emergence agitation in adult patients after general anesthesia.
- Half of participants will receive dexmedetomidine while the other half will receive propofol when emergence agitation happens.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients aged 18-65 years old after general anesthesia
- •with informed consent provided.
排除标准
- •age younger than 18 years or older than 65 years;
- •American Society of Anesthesiologists classification ≥Ⅲ;
- •preoperative lung dysfunction(including pneumonia,atelectasis,adult respiratory distress syndrome,acute lung injury and so on);
- •preoperative heart dysfunction(including sever cardiac coronary disease,unstable angina,LVEF≤30％，sick sinus syndrome，bradycardia:heart rate≤50bpm,second or third degree A-V block);
- •history of mental disease;
- •no informed consent provided;
- •uncontrolled hypertension(baseline blood pressure:SBP≥160mmHg or DBP≥110mmHg);
- •enrolled in other researches within 90 days;
- •allergic to intervening medicine.
- •BMI less than 18 or more than 30 kg/m2.
研究组 & 干预措施
Dexmedetomidine Group
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.
干预措施: Dexmedetomidine (Drug)
Propofol Group
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.
干预措施: Propofol (Drug)
结局指标
主要结局
The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group.
时间窗: 1 day
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.
次要结局
- Riker Sedation-Agitation Scale scores before and after intervention;(1 day)
- Heart rate before and after intervention;(1 day)
- The consumption of sufentanil in the post-anaesthesia care unit;(1 day)
- Nausea and vomiting scores when leaving the post-anesthesia care unit.(1 day)
- Duration in the post-anaesthesia care unit(1 day)
- Recovering quality: recovery scale(24 hours after surgery.)
- Mean blood pressure before and after intervention;(1 day)