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临床试验/NCT02034370
NCT02034370撤回不适用

Influence of Inter-scalene Blockade on Postoperative Episodic Desaturation in Patients at High Risk of Obstructive Sleep Apnea (OSA)

University of Michigan2 个研究点 分布在 1 个国家开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Incidence of postoperative sleep disordered breathing

研究概览

简要总结

Obstructive Sleep Apnea (OSA) is when a person stops breathing repeatedly during sleep. Breathing stops because the airway collapses and prevents air from getting into the lungs.This airway closure results in a decrease in the amount of oxygen that is in the blood. Anesthetics given during surgery are known to increase the tendency for a patient's airway to close immediately after surgery in the recovery room and to reduce the amount of oxygen in a patient's blood immediately after surgery. These two factors combined could have a profound effect on a patient's well being after surgery.

Recent advances in general anesthesia, pain medications, and surgical techniques have made outpatient surgery more common. Due to the increase in outpatient surgeries, pain management techniques that will work efficiently and for longer periods of time are necessary. One of these techniques is a nerve block, which coats the nerve with a numbing medication and blocks all pain from that area. Nerve blocks are routinely used along with general anesthesia for outpatient surgeries and help reduce or eliminate the need for IV or oral pain medicine after the surgery. Nerve blocks can provide good pain relief with early recovery and fewer side effects (nausea, vomiting, etc.) related to narcotic pain medicines.

Unfortunately, there are no studies that look at the effect of anesthesia and nerve blocks on breathing patterns and oxygen saturation levels after discharge from outpatient surgery. We therefore propose to study the changes in lung function tests and blood oxygen levels after a nerve block and general anesthesia for outpatient shoulder surgery. We would like to conduct a home sleep study including measuring oxygen levels while subjects are sleeping, before, during and after surgery, and test lung function both before and after surgery to see if there are any differences.

We will recruit 10 subjects with eligibility based on clinically indicated shoulder surgery and a nerve block. The study will be non-interventional during surgery.

It is possible that future screening for out-patient shoulder surgery includes preoperative overnight oxygen saturation measurement to identify patients at high-risk of changes in oxygen levels. These patients may benefit from hospital admission after surgery for close observation. Thus, this study could have significant implications for patient safety and resource utilization.

详细描述

History & Significance:

Obstructive sleep apnea (OSA) is a syndrome of sleep related airway obstruction (snoring) and reduction in blood oxygen levels affecting between 2% and 24% of the general population1. In other words, a person stops breathing repeatedly during sleep when they have OSA. Breathing stops because the airway collapses and prevents air from getting into the lungs. The impact of OSA on systemic heart and lung disease is slow and progressive over a course of years. Exposure to anesthesia increases the tendency for postoperative airway obstruction and reduction in oxygen levels2, both of which could have significant impact on patient well-being.

Recent advances in general anesthetics, opioid analgesic drugs and surgical techniques have made outpatient surgery common for a significant proportion of patients. It is estimated that approximately 50% of procedures currently performed in the University of Michigan Health System are day-case procedures, the vast majority of which require deep sedation or general anesthesia. The reduction in postoperative hospital based care has placed considerable emphasis on the efficient delivery of pain relief and has resulted in an increased usage of peripheral nerve blocks to reduce the need for intravenous sedative opioid analgesics and deep levels of anesthesia.

Shoulder surgery is a particularly good example where a nerve block in the neck region (typically an inter-scalene brachial plexus block) placed before anesthesia provides good pain relief with early recovery and less side effects directly related to opioid analgesics. Nevertheless, one of the side effects of the interscalene nerve block is temporary (12-18 hours) weakness of the diaphragm muscle on the same side as the block, due to phrenic nerve blockade. As a result, there is a change in the patient's breathing pattern which is typically compensated by increased work by other muscles in the respiratory system3. However, it is important to note that shoulder joint disease is more common in middle-aged patients who are typically at greater risk of OSA. The baseline abnormalities in respiration in OSA patients put them at increased risk of breathing abnormalities after the inter-scalene nerve block. As a result, this surgery presents unique challenges to the anesthesiologist looking to balance the benefit and risks of inter-scalene nerve blocks. Unfortunately, there are no studies that look at the effect of anesthesia and inter-scalene blocks on breathing patterns and oxygen saturation levels after discharge from outpatient surgery, as measured by spirometry, sleep studies and pulse oximetry. We therefore propose to study the changes in lung function tests and blood oxygen levels after an inter-scalene block and general anesthesia for outpatient shoulder surgery.

It is possible that future screening for out-patient shoulder surgery includes preoperative overnight oxygen saturation measurement to identify patients at high-risk of changes in oxygen levels. These patients may benefit from hospital admission after surgery for close observation. Thus, this study could have significant implications for patient safety and resource utilization.

研究设计

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

入排标准

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

入选标准

  • Any adult 18 years of age or older
  • Six or more of the following risk factors (P-SAP score): age > 43, male gender, body mass index >30, diabetes, high blood pressure, snoring at night, neck circumference > 17 inches, reduced thyromental distance, and/or modified Mallampati class of 3 or 4
  • Scheduled for an outpatient elective shoulder surgery for which an interscalene nerve block is scheduled for postoperative pain control along with a general anesthetic per the surgeon

排除标准

  • Age <18 years old
  • Patients on home oxygen therapy, existing OSA that is treated with Continuous Positive Airway Pressure or Bilevel Positive Airway Pressure machine
  • Unable or unwilling to provide consent
  • Prisoners
  • Non-English speaking
  • Hearing impaired
  • Chronic pain present for 3 months or longer requiring >3 pills a day of opioid pain/pain modifying medications
  • Daily use of gabapentin, pregabalin, tricyclic antidepressant, serotonin-norepinephrine reuptake inhibitor, tramadol, corticosteroids, or clonidine.
  • Preexisting nerve damage/peripheral neuropathy
  • Significant respiratory, kidney, liver or cardiovascular impairment
  • Coagulation/bleeding disorders
  • Uncontrolled diabetes
  • Drug or alcohol abuse
  • Uncontrolled anxiety, schizophrenia or bipolar disorder
  • Hearing impairment
  • American Society of Anesthesiologists class IV or V

结局指标

主要结局

Incidence of postoperative sleep disordered breathing

时间窗: The night after surgery

The incidence of postoperative sleep disordered breathing (apnea-hypopnea index) defined as ≥5 episodes per hour of \>50% reduction of expiratory air flow associated with a ≥4% reduction in oxygen saturation (referred to as ODI4 or oxygen desaturation index \> or = to 4 points drop in SpO2) that lasts for at least 10 seconds each as measured by the pulse oximeter.

次要结局

  • Changes in lung function(Once in Pre-op the day of surgery, and once in the Post Anesthesia Care Unit the day of surgery once the patient is sufficiently recovered from their procedure but before going home (all within 24 hours))

研究者

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

Satya Krishna Ramachandran

Assistant Professor of Anesthesiology

University of Michigan

研究点 (2)

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