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临床试验/NCT04874545
NCT04874545已完成4 期

Effect of Propfol Versus Sevoflurane on Auditory and Cognitive Function: A Compartive Study

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Paired associate learning test

研究概览

简要总结

Perioperative hearing loss is a rarely reported phenomenon. However, it occurs more frequently than most anaesthesiologists suspect. Perioperative hearing impairment is often subclinical and may go unnoticed unless audiometry is performed.

It can be conductive or sensorineural, unilateral or bilateral, and transient or permanent. Hearing loss has been reported following virtually every type of anaesthetic technique.

The hearing mechanism may be less susceptible to acoustic trauma during general anaaesthesia. But other mechanisms are capable of causing both conductive and sensorineural hearing losses (SNHL) in the perioperative period. The aetiologies include mechanical, traumatic, noise-induced, changes in cerebrospinal fluid (CSF) pressure, embolism, pharmacologic, and other miscellaneous causes.

Stress may influence central vestibular function in health and disease either directly through the actions of glucocorticoids (cortisol and corticosterone) on ion channels and neurotransmission in the brain, or indirectly through the effects of stress-related neuroactive substances (e.g., histamine, neurosteroids) on these structures.

The auditory brainstem response (ABR) provides a good estimate of the shape of the behavioral audiogram [and is thus an extremely useful tool for studying hearing sensitivity as well as the functionality of the auditory system.

An awareness of the potential for and the causes of hearing loss during anesthesia may permit the anesthesiologist to prevent or minimize the risk of significant hearing deficit. The suggestion that this risk be discussed in the preoperative period with patients who are at high risk for perioperative hearing loss may be good medical-legal advice. Better understanding of the incidence, causes, and prognoses for perioperative hearing loss is essential for the anesthesiologist.

Much Concern has been raised about the effects of anaesthetic drugs on cognition. Postoperative cognitive dysfunction may manifest as impairment in attention, memory, language or executive functions following surgery, and can persist for weeks, months, or more with varying severity. Such post-operative cognitive dysfunction can be quite mild and only diagnosed through psychometric assessment using specific neuropsychological tests.

AIM OF THE STUDY The aim of this work is to study the possible deleterious effect of propfol versus sevoflurane on auditory and cognitive function.

详细描述

Type and site of the study:

This study will be carried out at Beni-Suef university hospital, after approval by the department of Anaesthesiology, the local ethics and research committee and other involved departments, faculty of medicine, Beni-Suef University.

Date of the study:

The study will be performed starting from 1st of January 2021

Study design and population: This is a prospective randomized study that will be carried out on patients subjected to general anaesthesia.

研究设计

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

入排标准

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

入选标准

  • ASA I-II patients who are candidate for elective extra cranial surgery.
  • Male and female patients with age between 20-60 years

排除标准

  • Patients with a conductive or sensorineural hearing loss
  • Patients with a history of ear infection
  • Patients with a history of ear trauma
  • Patients using ototoxic or neurotoxic drugs
  • Patients with sternocleidomastoid muscle pathology (traumatic injury or weakness) that interfere with audiological assessment
  • Patient subjected to gross hemodynamic or ventilatory fluctuations during the operation
  • Patient who developed postoperative shock or major bleeding
  • Patient with a history of neurodegenerative disease, concomitant medical or metabolic illness known to affect cognition
  • Allergy to any drug used in the study.
  • Pregnancy.

研究组 & 干预措施

Propofol group

Experimental

Maintenance of anaesthesia will be done using Propofol total intravenous anesthesia (TIVA) 6-12 mg/ kg/h by syringe pump, 100 % O2.

干预措施: Propofol (Drug)

sevoflurane group

Active Comparator

Maintenance of anaesthesia will be done using sevoflorane1.5-2%, 100 % O2.

干预措施: Propofol (Drug)

结局指标

主要结局

Paired associate learning test

时间窗: 1 week

A test for assessment of cognitive function

Audiometry

时间窗: 1 week

A tool for assessment of auditory function

Paced Auditory Serial Addition Test

时间窗: 1 week

A test for assessment of cognitive function

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

Mona Hussein

Associate professor of Neurology

Beni-Suef University

研究点 (1)

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