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临床试验/CTRI/2020/09/027630
CTRI/2020/09/027630尚未招募3 期

Comparison of a single intravenous dose of magnesium sulphate or dexmedetomidine for attenuation of pressor response during selective neck dissection in head and neck malignancy:A double-blinded randomized interventional clinical trial

Christian Medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年9月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
To compare the effect of a bolus of either magnesium sulphate or

研究概览

简要总结

Primary tumour excision and selective neck dissection is the mainstay of treatment of oral cancers. The head and neck region is highly innervated and vascular and surgical stimulus causes an acceleration of the heart rate and blood pressure, resulting in increased bleeding and decreased visibility of the surgical field. 

Controlled hypotensive anaesthesia is an accepted method of providing a drier operative field, better visualization, more accurate dissection and reduced blood loss. Management of the intraoperative pressor response during surgical stimulus in head and neck surgeries continues to be a challenge. Inhalational anaesthetics combined with various intravenous agents are used to provide controlled hypotension during surgery.

Various drugs have been used to reduce the pressor responses to noxious stimuli. Among these, the efficacy of dexmedetomidine, an α 2-adrenoreceptor agonist that reduces the heart rate and cardiac output, hence the blood pressure has been established. Magnesium Sulphate too reduces the blood pressure by inhibiting catecholamine release and arteriolar vasodilation. Studies comparing magnesium sulphate with dexmedetomidine shows conflicting conclusions of the advantage of one over the other. There are not many studies comparing the effect of these two drugs during selective neck dissection dissections. We would like to compare magnesium sulfate as a safe, effective and less expensive alternative to dexmedetomidine in our patient population undergoing head and neck surgery. Hence the need for this study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All patients (ASA I and II) coming for selective neck dissection surgeries.

排除标准

  • 1.Patient refusal 2.ASA III and IV , 3.GFR <90ml/mt/1.73m2 4.Patients on beta blockers and calcium channel blockers.
  • 5.Known allergy to study drug 6.BMI >30 7.Vascular free flap surgery.

结局指标

主要结局

To compare the effect of a bolus of either magnesium sulphate or

时间窗: Every five minutes from the time of infusion bolus dose

dexmedetomidine on the hemodynamic response to surgical incision.

时间窗: Every five minutes from the time of infusion bolus dose

次要结局

  • 1) To compare the surgical field bleeding during neck dissection.(2) Comparison of duration of the attenuated pressor response..)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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