Effects of Dexmedetomidine at Different Doses on Hemodynamics and Recovery Quality in Elderly Patients Undergoing Hip Replacement Surgery Under General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes of baseline blood pressure
研究概览
简要总结
The purpose of this study is to find out appropriate dose range of dexmedetomidine to provide the elderly patients satisfactory sedation and analgesia with stable hemodynamics during perioperative period of hip replacement under general anesthesia.
详细描述
All patients will be screened to determine eligibility for study entry, and the patients who meet the eligibility requirements will be informed about the study and potential risks. After giving written informed consent, the patients will be randomized into different doses of dexmedetomidine groups and the comparative groups in a same ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥65yr, American Society of Anesthesiologists (ASA) physical status scale grade I-III, ready for HP; body weight between 45 and 75kg, body mass index (BMI) between 18 and 24kg/m2;
- •the health conditions generally well according to medical history, physical examination, and laboratory tests;
- •no signs of difficult intubation;
- •no history of dementia and mental problems;
- •normal cognitive function, ability to understand and comply with study procedures.
排除标准
- •Age <65 yr or >90 yr; BMI greater than 24 kg/m2; ASA grade higher than III;
- •Heart failure, severe arrhythmias, severe bradycardia (heart rate less than 40 beats/min), atrioventricular block of degree 2 or above, sick sinus syndrome, systolic blood pressure (SBP) ≥180 or <90 mmHg, diastolic blood pressure (DBP) ≥110 or <60 mmHg;
- •Severe liver or kidney dysfunction, severe infection, and other pathological conditions that interfere with study results.
- •Dementia, cerebrovascular accidents within 3 months, mental illness, epilepsy, and other adverse events that interfere with study results.
- •Patients with the conditions that block communication and preoperative assessment, such as serious hearing or visual impairment;
- •History of chronic analgesic use, long-term psychotropic medication use, alcohol or drug addiction.
研究组 & 干预措施
Group D0.25, Group D0.5, Group D0.75
Dexmedetomidine will be administered at different initial loading doses (0.25/0.5/0.75 μg/kg within 15min) following same maintained dosage ( 0.5μg/kg/h) in Group D0.25/D0.5/D0.75.
干预措施: Dexmedetomidine (Drug)
Group NS, Group MD
In Group NS, patients will be pumped 0.1ml/kg of normal saline for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation. In Group MD, patients will be administrated with midazolam 0.03mg/kg at the beginning of anesthesia induction.
干预措施: Normal saline (Drug)
Group NS, Group MD
In Group NS, patients will be pumped 0.1ml/kg of normal saline for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation. In Group MD, patients will be administrated with midazolam 0.03mg/kg at the beginning of anesthesia induction.
干预措施: Midazolam (Drug)
结局指标
主要结局
Changes of baseline blood pressure
时间窗: Through the whole perioperative period, an average of 10 hours
Changes of baseline blood pressure in each group, including systolic blood pressure, diastolic blood pressure and mean arterial pressure
Changes of baseline heart rate
时间窗: Through the whole perioperative period, an average of 10 hours
Changes of baseline heart rate in each group
Numbers of elderly patients with hypotension
时间窗: Through the whole perioperative period, an average of 10 hours
Hypotension is defined as systolic blood pressure \<90 mmHg or mean arterial pressure below \>20% of basal values.
Numbers of elderly patients with bradycardia
时间窗: Through the whole perioperative period, an average of 10 hours
Bradycardia is defined as heart rate \<50 beats/min or below \>20% of basal values.
次要结局
- Sedation changes after general anesthesia using Richmond agitation-sedation scale(before general anesthesia, up to 2 hours after general anesthesia)
- Pain changes after general anesthesia using visual analogue scale(before general anesthesia, up to 2 hours after general anesthesia)