跳至主要内容
临床试验/NCT01790971
NCT01790971暂停不适用

Low Dose Spinal Morphine for Patients With Obstructive Sleep Apnea (OSA) Undergoing Total Hip Arthroplasty (THA)

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1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
暂停
入组人数
40
试验地点
1
主要终点
Average Oxygen Desaturation Index (ODI) for the first 72 hours postoperatively.

研究概览

简要总结

Patients with Obstructive Sleep Apnea (OSA) appear to be especially vulnerable to medications that suppress pharyngeal muscle activity such as general anesthetics and opioids. Opioids can depress the ventilator response to airway obstruction and inhibit the awakening response to hypoxia and hypercarbia, resulting in central respiratory depression. OSA is therefore an important risk factor for serious postoperative complications, including perioperative death. While OSA is increasingly recognized as a serious perioperative concern, current clinical practices are highly inconsistent with regard to the management of surgical patients with OSA. Additionally, the relative safety of intrathecal opioids in this patient population remains unknown.

详细描述

Total hip and knee arthroplasty (THA and TKA) are among the most common orthopedic procedures performed worldwide1. They have been shown to reduce chronic pain, increase the ability to function independently, and improve quality of life2,3. With an aging and increasingly obese North American population, the uses of THA and TKA are increasing 4. One of the main challenges associated with THA as well as TKA continues to be the perioperative management of patients who are elderly or obese, and their associated co-morbidities. Both THA and TKA are commonly performed under neuraxial anesthesia. Neuraxial anesthesia has been reported to provide multiple benefits when compared to general anesthesia and/or systemic analgesia including superior post-operative analgesia5, reduced opioid consumption6, improved rehabilitation7, and reduced morbidity and mortality8-12. The addition of opioids to the neuraxial local anesthetic solution has been common practice since 1979, when morphine was first shown to provide effective and prolonged analgesia after intrathecal administration13. For both THA and TKA surgeries, intrathecal morphine provides effective analgesia14-16 allowing for a reduction of the dose of intrathecal local anesthetic (thus minimizing side effects)17, and has a marked postoperative opioid-sparing effect14-16. However, these benefits of intrathecal morphine must be weighed against its risks of pruritis, nausea/vomiting, urinary retention, and, of most concern, respiratory depression18.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults, aged 18-85
  • ASA physical status I-III
  • Suspected of having Obstructive Sleep Apnea(OSA) or previously diagnosed with OSA
  • Scheduled to undergo elective primary Total Hip or Knee Arthroplasty

排除标准

  • Chronic obstructive pulmonary disease
  • History of congestive heart failure
  • Valvular disease
  • Dilated cardiomyopathy
  • Implanted pacemaker or defibrillator
  • Diagnosed OSA who are undergoing continuous positive airway pressure (CPAP) treatment
  • Contraindications to spinal anesthesia
  • Contraindications to a component of multi-modal analgesia
  • Local anesthetic allergy
  • Anticipated surgical duration > 2.5hrs
  • Opioid tolerance (>250mg/24hr oral morphine equivalent pre-operatively)
  • History of significant cognitive or psychiatric condition that may affect patient assessment, or
  • Inability to provide informed consent.
  • Participation in other clinical studies

研究组 & 干预措施

Intrathecal morphine

Active Comparator

100μg of morphine will be added to the intrathecal mixture.

干预措施: Intrathecal Morphine (Drug)

No Intrathecal morphine

Active Comparator

Morphine will not be added to the intrathecal mixture.

干预措施: No Intrathecal Morphine (Drug)

结局指标

主要结局

Average Oxygen Desaturation Index (ODI) for the first 72 hours postoperatively.

时间窗: 72 hours

Oxygen Desaturation Index (ODI) is defined as the average number of episodes of desaturation ≥ 4% lasting at least 10 seconds, per hour of sleep. ODI will be measured with a nocturnal pulse oximeter.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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