跳至主要内容
临床试验/NCT02712749
NCT02712749已完成不适用

Use of Binaural Beat Premedication Reduces Post-operative Morphine Consumption in Elderly Patient Submitted to Knee Surgery

Azienda USL Toscana Nord Ovest2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Reduction on postoperative morphine consumption

研究概览

简要总结

The Investigators verify the effectiveness of "Binaural Beats" as premedication instrument in elderly patients submitted to orthopedic surgery to reduce anxiety , post operative pain and morphine consumption

详细描述

Need for surgery is increasing among elderly population, for increase in average life expectancy and for improved in surgical and anesthetic techniques.

A big problem in this kind of patients is the high incidence of delirium and cognitive impairment in post-operative period , which increase with age, depending on the type of intervention (especially Orthopaedics and Cardiac Surgery) and the administration of some agents, particularly sedatives and opioids .

Premedication is usually carried using anxiolytic and / or narcotic drugs in order to reduce anxiety and discomfort related to the intervention and anesthesia. The preoperative anxiety in fact increases the demand for intra and post operative anesthetics and analgesics and contribute to increase the post operative pain. For this reason the use of a pharmacological premedication is controversial in elderly patient, for the risk of side effects of drugs on one side, and for the other to the discomfort resulting from the increased level of anxiety in absence of premedication. .

Some recent surgical guidelines warn against premedication drug in patients over sixty-five, considering that occurrence of delirium and cognitive impairment may worsen the prognosis, limiting the use of such drugs to what is strictly necessary and only in the immediacy of the surgical act.

To reduce perioperative pain and anxiety , some authors used "Binaural Beats". This simple technique , described for the first time since by Gerald Oster , include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. The interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. For example if you give an acoustic stimulus of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz to the opposite ,ear the person who listens to these stimuli will perceive a "Binaural Beat" of 4 Hz caused by the difference between the two frequencies. These Binaural Beats are of interest because they have been thought to cause hemispheric synchronization and influence the EEG frequency like light stimulation .

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects over 65 years aged candidated to elective major orthopedic surgery
  • Stable hemodynamic and clinical conditions (ASA 1/2, Goldman Desky Class 1)
  • Absence of cognitive impairment (MMSE greater than 24)
  • Valid consent expression to the study participation
  • No history of epilepsy and other chronic neurological diseases that may interfere with the study procedures.
  • Good collaboration in activities provided by the study
  • No abnormalities at audiometric testing for the frequencies between 256 and 260 Hz.

排除标准

  • Insufficient level of cooperation or hearing loss
  • Contraindications to the use of binaural beats (a history of epilepsy)
  • Treatment with anti-anxiety drugs or major tranquillizers
  • Clinical Instability defined as the inclusion criteria
  • Denial of informed consent to participate in the study
  • Presence of cognitive impairment (MMSE less than or equal to 24)
  • Presence of neurological diseases or neurological damage that interfere with the study procedures.

结局指标

主要结局

Reduction on postoperative morphine consumption

时间窗: in the first post-operative day

Difference of cumulative morphine consumption between Binaural Beat group vs Control group through patient-controlled analgesia device (PCA)

次要结局

  • Reduction in the level of preoperative anxiety assessed by State Anxiety inventory (STAI-1)(at 20 minutes after a binaural beat listening session)

研究者

发起方
Azienda USL Toscana Nord Ovest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Tani

Medical Doctor

Azienda USL Toscana Nord Ovest

研究点 (2)

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