跳至主要内容
临床试验/NCT03738059
NCT03738059Unknown早期 1 期

Assessment of the Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy: Randomized Control Study

Assiut University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
120
试验地点
1
主要终点
arterial blood pressure change

研究概览

简要总结

Skull pins are used to immobilize the head during craniotomy. Fixation of skull pins causes acute hemodynamic changes which may affect cerebral autoregulation and hence cerebral blood flow. Therefore, maintenance of stable hemodynamic parameters during skull pin placement under general anesthesia is crucial to ensure adequate cerebral perfusion and prevention of acute rise of intracranial pressure

详细描述

Many different strategies have been used to minimize the hemodynamic responses to skull pin placement with varying results. Local anesthetic infiltration at pin application sites has been used but was always unsuccessful in obtunding the hemodynamic responses to skull pin placement. Dexmedetomidine, an alpha-2 adrenoceptor agonist, has been recently introduced as a sedative for patients on mechanical ventilation. In addition to its sedative effect; Dexmedetomidine has significant analgesic qualities and has been labeled as "analgesia-sparing". To the best of the investigator's knowledge, few studies investigated Dex use to suppress hemodynamic responses to skull pinning. The aim of the current study was to evaluate the lowest effective dose of Dexmedetomidine in attenuating the hemodynamic responses to skull pin placement for craniotomies. Lidocaine, administered subcutaneously at the head-holder pin sites, was more effective in preventing the blood pressure response to skull-pin than was deepening the level of anesthesia.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 120 Adult patients,
  • undergoing elective craniotomy
  • ASA I and II patients

排除标准

  • patients undergoing craniotomy for emergency surgery,
  • raised ICP,
  • obese patients (body mass index >30 kg/m2 for males and 28 kg/m2 for females),
  • patients having systemic comorbidities (cardiac, renal, hepatic, and endocrinal),
  • hypertensive patients (including those detected after admission),
  • patients undergoing intracranial aneurysm clipping

研究组 & 干预措施

group IV (Dex 0.2)

Experimental

will receive intravenous Dex 0.2 mcg/kg.

干预措施: Dexmedetomidine Injection [Precedex] (Drug)

group I (placebo)

Placebo Comparator

will receive intravenous normal saline (NS)

干预措施: normal saline 0.9% (Other)

group II (Dex 0.5)

Experimental

will receive intravenous Dex 0.5 mcg/kg

干预措施: Dexmedetomidine Injection [Precedex] (Drug)

group III (Dex 0.25)

Experimental

will receive intravenous Dex 0.25 mcg/kg

干预措施: Dexmedetomidine Injection [Precedex] (Drug)

结局指标

主要结局

arterial blood pressure change

时间窗: before Skull Pin Insertion till 20 minutes

systolic and diastolic blood pressure mmhg

heart rate change

时间窗: before Skull Pin Insertion till 20 minutes

heart rate beat/minute

次要结局

未报告次要终点

研究者

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

Ghada Mohammed AboelFadl

principal investigator

Assiut University

研究点 (1)

Loading locations...

相似试验