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临床试验/CTRI/2017/01/007667
CTRI/2017/01/007667已完成不适用

Evaluation of Dexmedetomidine as anaesthetic adjunct to Propofol during Bispectral Index guided anaesthesia for cerebello-pontine angle surgeries

未提供1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年6月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Quantification of anaesthetic and analgesic sparing effect of dexmedetomidine.

研究概览

简要总结

Cerebello-pontine angle (CPA) surgeries tend tocarry the surgeon’s knife uncomfortably close to the brainstem, putting variouscranial nerves at risk for damage. For preventing this, cranial nerve monitoringusing continuous electromyography (EMG) of the regional motor supply of thenerve or evoked potentials is utilized. It has been recommended in literature that propofolas a primary hypnotic component of anaesthesia would provide better conditionsfor cranial nerve monitoring compared to inhalational agents. High dose of propofol has certain undesirableeffects as such as occasional delayed awakening, metabolic acidosis withincreased lactate levels and myocardial depression causing hypotension. Dexmedetomidine has been used as an anaesthetic adjunct to propofol and has been shown to reduce propofol requirements, whenused along with processed EEG monitoring. Inthis study, we propose to quantify the probable dose reduction of propofol withuse of dexmedetomidine during CPA surgeries and compare the recovery profile,adequacy of cranial nerve monitoring, acid base status and intraoperative haemodynamicswith and without the usage of dexmedetomidine.

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
16.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing Cerebello-pontine angle surgeries with cranial nerve monitoring.

排除标准

  • Patients with evidence of sino-atrial nodal or atrio-ventricular nodal bradyarrhythmia on ECG, baseline heart rate < 50/min.
  • Patients with known history of hypertension and being treated with anti-hypertensive drugs.
  • Patients on tricyclic antidepressant, clonidine, monoamine oxidase-inhibitor therapy.
  • Patients with evidence of impaired hepatic/renal function according to past history or preoperative biochemistry parameters.
  • Need for intraoperative inotrope/vasopressor drug.
  • Allergy to egg/propofol 7)Absence of cranial nerve monitoring during surgery.

结局指标

主要结局

Quantification of anaesthetic and analgesic sparing effect of dexmedetomidine.

时间窗: End of anaesthesia.

次要结局

  • 1)Recovery from anaesthesia based on time to opening eyes, time to following commands and time to extubation after anaesthetic withdrawal.(2)Evaluate the effect propofol alone and propofol-dexmedetomidine combination on acid base status.)

研究者

发起方
未提供

研究点 (1)

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