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临床试验/NCT01179100
NCT01179100撤回4 期

The Effects Of Lidocaine Infusion On The Recovery Of Cognitive Function Following General Anesthesia In Elderly Patients Undergoing Orthopedic Surgeries Requiring A Minimum Two Day Hospitalization

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家开始时间: 2011年6月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Post-operative cognitive function

研究概览

简要总结

This study will evaluate the effect of intraoperative lidocaine infusion on postoperative orientation and concentration in elderly patients having general anesthesia for orthopedic surgeries requiring a minimum 2 days hospitalization.

This study will also aim to determine whether intraoperative lidocaine infusion during general anesthesia improves recovery and patient outcome, as well as to determine whether lidocaine infusion decreases postoperative opioid (pain medication) usage.

详细描述

Advances in surgical techniques and anesthetic care have resulted in a substantial reduction in peri-operative morbidity and mortality in the elderly. However, post-operative cognitive dysfunction (POCD), as well as episodic post-operative delirium, are still recognized as significant complications following surgery in the elderly. Post-operative cognitive dysfunction is characterized by impairment of memory, concentration, language, comprehension, and social integration. Conversely, post-operative delirium is characterized by intermittent, short-term impaired cognition, disorientation, and abnormalities in memory and perception, which has been shown to lead to increased morbidity and mortality, delayed functional recovery, and prolonged hospital stays. Elderly patients are particularly sensitive to the central nervous system effects of many peri-anesthetic drugs, including benzodiazepines, barbiturates, opioids, and volatile anesthetics, which may play a role in POCD and consequent patient outcomes. Randomized clinical trials have demonstrated no difference in the recovery of cognitive function between commonly used volatile anesthetic agents.

Several simple, bedside tests are available to assess cognitive function and differentiate between cognitive dysfunction and an episode of delirium. The Confusion Assessment Method (CAM) is a standardized rating of delirium that has been validated and has high inter-observer reliability. The CAM criteria are the most commonly used method for diagnosing delirium in hospitalized patients. The Mini-Mental Status Examination (MMSE) and the Abbreviated Mental Test are tools used to assess cognitive function at the bedside.

Lidocaine is one of the most commonly used sodium-channel blockers in the medical armamentarium. It has long been used for its local anesthetic and anti-arrhythmic properties, and has been studied as an adjunct to general anesthesia. While lidocaine is cardio-toxic in excessive doses, the therapeutic and toxic levels are well-documented and wide, making lidocaine a drug with a favorable safety profile. Randomized clinical trials have shown perioperative lidocaine infusions to decrease postoperative pain scores, reduce postoperative opioid requirements, shortens hospital stays, improves postoperative recovery and fatigue score when administered as an adjuvant during surgery. Lidocaine has analgesic, antihypertensive, and anti-inflammatory properties. To date, no clinical trials have been conducted to establish the relationship between lidocaine infusions and postoperative recovery, particularly cognitive function, in elderly orthopedic surgery patients. It is therefore the aim of this study to evaluate the effects of lidocaine infusion on postoperative cognitive function in elderly patients having general anesthesia for orthopedic surgery, and to assess whether intraoperative lidocaine infusion decreases postoperative opioid usage and improves recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Scheduled to undergo orthopedic surgery under general anesthesia requiring a minimum two-day hospitalization (e.g. THA, TKA, hardware removal)
  • 65 years of age or older
  • ASA Physical Classification I - IV
  • Willingness and ability to sign an informed consent document
  • English-speaking

排除标准

  • Inability to consent or complete cognitive assessments
  • Inability to use a PCA system
  • Allergy to lidocaine or any other medication administered as part of this protocol
  • Emergency surgery

研究组 & 干预措施

Normal Saline

Placebo Comparator

Normal Saline: Calculated and adjusted to match loading dose and infusion rate of lidocaine equivalent adjusted for weight.

干预措施: Lidocaine (Drug)

Lidocaine

Active Comparator

干预措施: Lidocaine (Drug)

结局指标

主要结局

Post-operative cognitive function

时间窗: 1 month

Pre-operative cognitive function tests, including the CAM, MMSE, and the Abbreviated Mental Test, will be administered to establish baseline cognitive function. Then compared with the results of the postoperative cognitive function tests.

次要结局

  • Patient satisfaction using a verbal rating scale from 0 to 100(1 month)
  • Hospital stay(1 week)
  • Postoperative pain(1 month)
  • Opioid consumption obtained from the recorded data(1 month)
  • Postoperative nausea and vomiting using a Verbal Rating Scale(1 month)
  • Return to normal activities of daily living using follow up questionnaires Return to normal activities of daily living using follow up questionnaires(1 month)

研究者

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

Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Cedars-Sinai Medical Center

研究点 (1)

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