Influence of Small Doses Dexmedetomidine to the Elderly Patients' Emergence Agitation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- evaluation of agitation
研究概览
简要总结
Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of emergence agitation of children and adults,especially in elderly patients(>64 years) after using sevoflurane anesthesia.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obtain informed consent;
- •patients whose selective under general anesthesia colorectal cancer or esophageal cancer radical operation time > 2h;
- •the American society of anesthesiologists (ASA) class I-II;
- •age>64 years old;
- •BMI<28kg/㎡;
排除标准
- •systolic pressure≥180mm Hg or<90mm Hg, diastolic pressure≥110mm Hg or< 60mm Hg;
- •serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
- •patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
- •HR<50times/min
- •a history of mental illness or a long history of taking medicine of psychiatric drugs and chronic analgesics
- •a history of alcoholism
- •diseases of the neuromuscular
- •a tendency to malignant hyperthermia
- •allergy to test drugs or have other contraindications
- •participated in other clinical drug researches over the past 30 days
研究组 & 干预措施
Sevoflurane & Dexmedetomidine
inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Dexmedetomidine 0.2µg/kg/h.
干预措施: Sevoflurane (Drug)
Sevoflurane & Dexmedetomidine
inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Dexmedetomidine 0.2µg/kg/h.
干预措施: Dexmedetomidine (Drug)
Sevoflurane & Placebo
inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Placebo(for Dexmedetomidine )0.05ml/kg/h.
干预措施: Sevoflurane (Drug)
Sevoflurane & Placebo
inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Placebo(for Dexmedetomidine )0.05ml/kg/h.
干预措施: Placebo(for Dexmedetomidine) (Drug)
结局指标
主要结局
evaluation of agitation
时间窗: the duration of PACU room stay,expect 30 minutes
stay in the PACU room after operation,measure the score of Aono's four-point scale(AFPS) every two minutes.
the amount of drugs
时间窗: the duration of hospital stay,expect 5 weeks
when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using
number of agitation
时间窗: the duration of hospital stay,expect 5 weeks
when stay in the hospital, measure the number of agitation.
evaluation of pain
时间窗: the duration of PACU room stay,expect 30 minutes
stay in the PACU room after operation,measure the score of numeric rating scale(NRS) every two minutes.
次要结局
- the mean arterial pressure(from the beginning of induction to skin closure, up to 1 hour)
- heart rate(from the beginning of induction to skin closure, up to 1 hour)