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临床试验/NCT02476981
NCT02476981已完成不适用

Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care

Hallym University Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
The frequencies of oxygen desaturation during procedures

研究概览

简要总结

This randomised, double-blind study compared remifentanil and dexmedetomidine for monitored anaesthesia care (MAC) during minimally invasive corrections of vertebral compression fracture (vertebroplasty (VP) and kyphoplasty (KP)).

In total, 80 ASA physical status I-III patients scheduled for VP and KP randomly received remifentanil or dexmedetomidine to maintain OAA/S scale ≤ 4 during the procedures. Multiple hemodynamic variables of patients were recorded and the frequency of oxygen desaturation, respiratory depression, intraoperative need for other opioids, recovery time, operator satisfaction score, and patients' overall pain experiences were also compared.

The investigators are expecting that both remifentanil and dexmedetomidine appear to be quite safe for MAC during VP and KP. Thus, dexmedetomidine may be an alternative for MAC during VP and KP in elderly patients.

详细描述

All patients fasted for 8 h before the procedure and were premedicated with midazolam 0.02 mg/kg. In the prone position, patients were monitored by ECG, non-invasive blood pressure, and pulse oximetry, and received supplemental oxygen (3 L/min) via a nasal cannula during the procedure.

Study drugs were prepared in 20 mL and 50 mL syringes to maintain a double-blind design. One anaesthesiologist administered normal saline or dexmedetomidine contained in the 20-mL syringe during the initial 10 min for loading dose of dexmedetomidine. Then, another investigator who did not know which syringes contained remifentanil or dexmedetomidine adjusted the infusion rate with a 50-mL syringe according to patients' response. After all patients in both groups received a bolus dose of propofol 0.3 mg/kg, patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h, and patients receiving dexmedetomidine were given that drug at 0.3-0.4 µg/kg over 10 min, followed by continuous infusion of dexmedetomidine 0.2-1 µg/kg/h throughout the procedure. Levels of patient sedation were checked during the procedure and infusion rates of the study drugs were adjusted to maintain alertness/sedation below 4 on the OAA/S scale.

Mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO2), respiratory rate (RR), and adverse effects of the study drugs were recorded during the procedure. Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg. Duration of PACU stay was also recorded.

Operator satisfaction score and patient's overall pain experience were also recorded.

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, Care Provider, Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who are scheduled for vertebroplasty or kyphoplasty under monitored anesthesia care
  • ASA status I-III
  • aged more than 65 years old.

排除标准

  • obesity (BMI > 30 kg/m2)
  • hypotension (systolic blood pressure < 100 mmHg)
  • bradycardia (heart rate < 60 bpm)
  • heart block
  • baseline oxygen desaturation (SpO2 < 90%)
  • sleep apnea
  • asthma, or chronic obstructive pulmonary disease
  • those who refused to give informed consent

研究组 & 干预措施

Remifentanil

Experimental

Remifentanil is commonly used in monitored anesthesia care because of its rapid onset and short duration of action.

干预措施: Remifentanil (Drug)

Dexmedetomidine

Experimental

Dexmedetomidine is a highly selective α 2 adrenergic agonist and has both sedative and analgesic properties, and rarely causes respiratory depression.

干预措施: Dexmedetomidine (Drug)

midazolam

Other

Midazolam is commonly used before induction for its anxiolytic effect.

干预措施: Remifentanil (Drug)

midazolam

Other

Midazolam is commonly used before induction for its anxiolytic effect.

干预措施: Dexmedetomidine (Drug)

midazolam

Other

Midazolam is commonly used before induction for its anxiolytic effect.

干预措施: midazolam (Drug)

propofol

Other

Propofol is the most commonly used in sedative analgesia for its rapid onset and recovery time.

干预措施: Remifentanil (Drug)

propofol

Other

Propofol is the most commonly used in sedative analgesia for its rapid onset and recovery time.

干预措施: Dexmedetomidine (Drug)

propofol

Other

Propofol is the most commonly used in sedative analgesia for its rapid onset and recovery time.

干预措施: propofol (Drug)

ephedrine

Other

Adrenergic agonist to treat hypotension

干预措施: Remifentanil (Drug)

ephedrine

Other

Adrenergic agonist to treat hypotension

干预措施: Dexmedetomidine (Drug)

ephedrine

Other

Adrenergic agonist to treat hypotension

干预措施: ephedrine (Drug)

结局指标

主要结局

The frequencies of oxygen desaturation during procedures

时间窗: About 1 hour through the procedures

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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