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临床试验/NCT02965586
NCT02965586Unknown1 期

Efficacy of Intrathecal Versus Intravenous Dexmedetomidine for Prevention of Post Spinal Anesthesia Shivering in Patients Undergoing TURP

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
90
试验地点
1
主要终点
Change in postoperative shivering

研究概览

简要总结

compare the efficacy of intrathecal versus intravenous dexmedetomidine in attenuation and prevention of shivering in TURP under spinal anesthesia in a randomized controlled trial.

详细描述

Shivering is a frequent complication following SA. It is distressing and unpleasant experience for patients. The incidence of shivering has been reported to be about 36-85% after SA. It is more common in TURP that may be due to absorption of large amount of irrigating fluid at room temperature. Shivering may occur as a response to hypothermia. However, it may also occur in normothermic patients. SA impairs the thermoregulation system by inhibiting tonic vasoconstriction below the level of anesthesia through sympathetic and somatic neural blockade. With internal redistribution of heat from the core to the peripheral compartment, the loss of thermoregulatory vasoconstriction results in increased heat loss from body surfaces in excess of metabolic heat production. Excessive shivering can result in an increased oxygen demand up to 400% of normal and induce metabolic derangements such as hypoxemia, lactic acidosis and hypercarbia. Therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves.

Considering these undesirable consequences of shivering, measures to prevent in the postoperative period are important. Various drugs have been investigated for the prevention or treatment of postoperative shivering, including meperidine, ketamine, tramadol, doxapram and dexmedetomidine.

Dexmedetomidine is an α 2-agonist that decreases vasoconstriction and shivering thresholds and when administered with meperidine additively reduces the shivering threshold in healthy volunteers. Intraoperative dexmedetomidine reduces postanesthetic shivering as does meperidine after surgery.

One bolus dose of dexmedetomidine 1 μg/kg with or without continuous infusion was used in the previous antishivering studies. Dexmedetomidine also has sedative and analgesic effects in the postoperative period. Patients who received an intraoperative injection of dexmedetomidine were more sedated after surgery than those who received placebo. This can be a disadvantage particularly for patients undergoing outpatient surgery.

Addition of intrathecal dexmedetomidine to heavy bupivacaine 0.5% was more advantageous than fentanyl with special regard to its analgesic properties in diabetic surgical patients. Few studies have been done to evaluate the efficacy of intrathecal dexmedetomidine in attenuation and prevention of shivering in TURP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients scheduled to undergo elective trans-urethral resection of the prostate(TURP) under spinal anesthesia.

排除标准

  • Obese patients (BMI > 27)
  • those with hypo- or hyperthyroidism,
  • cardiopulmonary disease,
  • psychological disorders,
  • blood transfusion during surgery,
  • Parkinsonians disease, and
  • an initial body temperature above 38.0˚C or below 36.0 ˚C

研究组 & 干预措施

intravenous dexmedetomidine group

Active Comparator

intrathecal 2.5 ml of heavy bupivicaine 0.5% pulse 0.5 mg morphine and will receive intravenous dexmedetomidine infusion as prepared. Dexmedetomidine will be diluted to a volume of 50 ml (4 mg ml-1) and presented as coded syringes by an anesthesiologist. I.V. bolus of dexmedetomidine 1 ug kg-1 administered by a syringe pump over a 10-min period followed by an infusion of 0.4 ug kg-1h-1 dexmedetomidine during the surgery. Just after intrathecal injection, all drugs were infused intravenously. The infusions will be stopped at the end of surgery.

干预措施: intrathecal (Drug)

intrathecal dexmedetomidine group

Active Comparator

intrathecal2.5 ml of heavy bupivicaine 0.5% pulse 0.5 mg morphine and dexmedetomidine (10µg) and will receive an equal volume of saline intravenously

干预措施: intrathecal (Drug)

control group

Placebo Comparator

intrathecal 2.5 ml of heavy bupivicaine0.5% pulse 0.5 mg morphine and will receive an equal volume of saline intravenously

干预措施: intrathecal (Drug)

结局指标

主要结局

Change in postoperative shivering

时间窗: 0, 10,20,30,40, 50,60 min

Shivering will be assessed by Crossley and Mahajan scale where 0= No shivering, 1= Cyanosis and piloerection, 2 = Visible tremors only in one muscle group, 3 = Visible tremors in more than one muscle group, and 4 = intense shivering, tremors of the head, arm.

次要结局

  • side effect(0, 10,20, 30, 40, 50, 60 min)
  • sedation score(0, 10,20, 30, 40, 50, 60 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shereen Mamdouh

Lecturer of anesthesia, ICU and pain managment

Assiut University

研究点 (1)

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