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临床试验/NCT04250233
NCT04250233已完成不适用

Prospective Observational Study of Postoperative Respiratory Rate After Cesarean Delivery Among a Convenience Sample of Women Undergoing Spinal Anesthesia With and Without Neuraxial Opioids

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Respiratory rate ≤8

研究概览

简要总结

The study proposal summarizes aspects related to respiratory rate in women who undergo spinal anesthesia for cesarean delivery who receive or do not receive neuraxial opioids

详细描述

Respiratory monitoring device will be used to count respiratory rate continuously, as opposed to the intermittent nursing respiratory rate (RR) counts once per hour. The device counts respiration (RR) using a sticker placed by on the neck to detect vibrations made by respiration. This overcomes the specific limitation of capnography that requires wearing the nasal cannula.

Prospective, observational study with institutional review board (IRB) approval. Women who undergo elective cesarean delivery under neuraxial block receive neuraxial opioids for postoperative analgesia.

Potential study recruits will be approached prior to the cesarean delivery anesthesia assessment. Suitable women will be informed that neuraxial morphine is the gold-standard analgesia, however many women suffer nausea, vomiting and pruritus (itching) and may prefer an alternative analgesic or a lower dose of morphine. All women will receive intrathecal fentanyl as an adjuvant to the bupivacaine anesthesia. This fentanyl may also cause pruritus however this is limited to the 2-hour duration of the effect of the fentanyl.

Women will be offered standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 10-25mic; and low dose intrathecal morphine mic). Alternatively, women will be offered an alternative anesthesia option: 1) heavy bupivacaine 10 mg; fentanyl 10-15 mic with an ultra-low dose, 50 mic of morphine, or 2) heavy bupivacaine 10 mg; fentanyl 10-25 mic without intrathecal morphine + postoperative bilateral quadratus lumborum block (QLB), transversus abdominis plane (TAP) or erector spinus block (ESP). For patients who select block without intrathecal morphine, the choice of block will depend on anesthesiologist's decision.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status class II or III
  • age between 18 and 50
  • gestational age greater than 37 completed weeks
  • singleton pregnancy. In contrast to previous studies
  • we do not plan to exclude obese women and those with suspected sleep apnea.

排除标准

  • Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
  • narcotic administration in the previous 2 hours
  • inability to adequately understand the consent form
  • moderate-severe asthma, inability to receive morphine
  • sensitivity to sticker
  • skin conditions.

结局指标

主要结局

Respiratory rate ≤8

时间窗: up to 24 hours

Our primary study aim is to report the number of women with RR≤8 at any time point after the cesarean delivery using the continuous respiratory monitoring device.

次要结局

  • side effects(up to 24 hours)
  • heart rate(up to 24 hours)
  • antiemetic(up to 24 hours)
  • additional analgesia(up to 24 hours)
  • duration of monitor period(up to 24 hours)
  • patient experience(up to 24 hours)
  • respiratory rate per min(up to 24 hours)
  • oxygen saturation(up to 24 hours)
  • apnea(up to 24 hours)
  • nurse outcomes(up to 24 hours)
  • patient anesthesia selection(up to 24 hours)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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