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临床试验/NCT03137615
NCT03137615已完成不适用

An Observational Study of the Cardiovascular Response to Infiltration of Local Anaesthetic Into the Nasal Septum in Patients Undergoing Trans-sphenoidal Resection of a Pituitary Lesion

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 15 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
主要终点
Change in blood pressure after administration of local anaesthesia

研究概览

简要总结

The purpose of this study is to determine the effects on the heart of injecting local anaesthetic into the nose prior to surgery on the pituitary gland?

详细描述

People sometimes require surgery on their pituitary gland. This is a gland at the base of your brain which secretes hormones. At the Royal Hallamshire Hospital the investigators are currently conducting a study into the effects of local anaesthetic (a medicine which causes numbness) injection on patients undergoing this particular type of operation.

After patients are anaesthetised (asleep) but before surgery starts the surgeon injecst a local anaesthetic solution into the nose. This is routine practice and is done to provide pain relief afterwards and also to decrease the amount of bleeding during the operation to ensure that the surgeon has a good view.

The investigators have known for a long time that local anaesthetic affects the heart rate and blood pressure, however the investigators would like to describe exactly how, in much more detail.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any adult patient undergoing trans-sphenoidal pituitary surgery.

排除标准

  • Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery.

研究组 & 干预措施

Pituitary Surgery

Patients having pituitary gland surgery

Inclusion criteria - Any adult patient undergoing trans-sphenoidal pituitary surgery.

Exclusion criteria - Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery

干预措施: Pituitary surgery (Procedure)

Pituitary Surgery

Patients having pituitary gland surgery

Inclusion criteria - Any adult patient undergoing trans-sphenoidal pituitary surgery.

Exclusion criteria - Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery

干预措施: local anaesthetic injection (Drug)

结局指标

主要结局

Change in blood pressure after administration of local anaesthesia

时间窗: 5 minutes

Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.

次要结局

  • Change in heart rate after administration of local anaesthesia(5 minutes)
  • Change in cardiac output after administration of local anaesthesia(5 minutes)
  • Change in systemic vascular resistance after administration of local anaesthesia(5 minutes)

研究者

申办方类型
Other
责任方
Sponsor

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