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临床试验/NCT00932386
NCT00932386撤回4 期

The Effects of Dexmedetomidine on Tourniquet Pain Associated With Lower Extremity Surgeries Under General Anesthesia in Same Day Elective Patients

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
hemodynamic stability

研究概览

简要总结

This study is being done to determine if the drug known as dexmedetomidine improves the way we care for patients when their surgery involves the use of a tourniquet on the leg. A tourniquet is sometimes used for lower leg or foot surgery to decrease the blood loss for the patient and to make it easier for the surgeon to do his work.

详细描述

The study will be a prospective, randomized, double blinded, and placebo controlled clinical trial. The subject population will consist of patients ages 18 to 80 undergoing same day, lower extremity surgery involving the use of a tourniquet with a minimal surgical time of 60 minutes. Subjects will be recruited on the day of surgery, after consultation with the primary surgeon as to the use of a tourniquet and the anticipated tourniquet time. Subjects will be approached while awaiting surgery either on E yellow or Same day Surgery in the Doctor's Office Complex. The study will be explained. The subject and family members will be given an opportunity to ask questions and if agreeable the subject will be asked to provide written consent. Standard American Society of Anesthesiologists monitors will be used including pulse oximetry, electrocardiogram, and non-invasive blood pressure monitoring. Both groups will have an infusion running.

The experimental group (n= 40) will have a Dexmedetomidine infusion at 0.5 mcg/kg/hr without a loading dose. The control group (n= 40) will have an equivalent volume of 0.9% normal saline infusing.

Induction will commence after the initiation of the infusion and will be identical for both groups: Midazolam 2mg IV, Fentanyl 1-2 micrograms/kg, Lidocaine 1mg/kg, and Propofol 1.5 to 2 mg/kg. Following induction an appropriately sized Laryngeal Mask Airway (LMA) will be placed. A second intravenous line (preferably 18Gauge or larger) will be placed in the opposite upper extremity to collect blood samples. Prior to sampling a waste of 10milliLiters will be withdrawn and later returned to the patient. Anesthesia will be maintained with isoflurane at a Minimum Alveolar Concentration of 0.8 to 1.2. Mean arterial pressures that exceeds 130mmHg or >30% above baseline or heart rate(HR)s >110 bpm will first be treated with additional doses of Fentanyl every two minutes for a total dose of 5mcg/kg. If there is no response following the total dose of Fentanyl then within two minutes further treatment with Labetalol consisting of titrated doses starting at 5mg IV. Rescue doses of Hydralazine up to 20mg are allowed to treat hypertension not responsive to Fentanyl and Labetalol

Measurements:

The following measurements will be collected. Time 0 : In Operating Room holding area Baseline MAP, Heart Rate(HR) , and Respiratory Rate (RR) will be recorded A baseline Numeric Ration Scale Pain Score determined

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing lower extremity surgery which requires the use of an inflated tourniquet ASA rating I-III

排除标准

  • Allergy to alpha 2 adrenergic agonists
  • Uncontrolled hypertension (SBP>180mm HG, Diastolic Blood Pressure >110mmHG)
  • Heart block greater than first degree or cardiac muscle at risk for reversible ischemia
  • Airway anatomy that contra-indicates the use of a laryngeal airway mask expected tourniquet time less than 60 minutes or greater than 150 minutes
  • Subjects who do not have a phone

研究组 & 干预措施

dexmedetomidine Hcl infusion

Experimental

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist, which possesses hypnotic, sedative, anxiolytic, sympatholytic and analgesic properties.

干预措施: Dexmedetomidine Hcl infusion (Drug)

normal saline

Placebo Comparator

干预措施: normal saline (Drug)

结局指标

主要结局

hemodynamic stability

时间窗: mean arterial pressure, heart rate and respiratory rate prior to surgery and at 5 minute intervals during surgery. same assessment in PACU until ready for discharge from PACU

次要结局

  • markers for stress response(prior to tourniquet inflation, 60 minutes after tourniquet inflation, 120 minutes after tourniquet inflation and 30 minutes after tourniquet release.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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