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临床试验/NCT06371131
NCT06371131招募中不适用

Effect of Right⁃Stellate Ganglion Block on Postoperative Nausea and Vomiting in Patients Undergoing Thyroid Surgery

The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Incidence of Postoperative nausea and vomiting

研究概览

简要总结

Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as thyroid surgery is even up to 70-80%. PONV not only increased discomfort and prolonged hospital stay; Severe cases can lead to wound dehysis, acid-base imbalance, water and electrolyte metabolism disorders, seriously affect the prognosis of patients. Although various prevention and treatment measures have been adopted in clinical practice, it still cannot be completely eliminated. Therefore, postoperative nausea and vomiting of thyroid is still a concern in clinical anesthesia work, so it is urgent to explore more simple and effective measures to prevent thyroid PONV. SGB is the injection of local anesthetics into loose connective tissue containing stellate ganglion. It has a clear effect on postoperative analgesia of thyroid surgery, and can play a certain role in preventing thyroid PONV by reducing the application of perioperative opioids. Few studies have reported that the incidence of PONV can be significantly reduced after the application of SGB in patients with thyroid surgery, which provides a certain basis for the prevention of thyroid PONV. Therefore, this study aims to explore the effect of right stellate ganglion block on preventing postoperative nausea and vomiting of thyroid, and to explore the possible mechanism of action.

详细描述

Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as thyroid surgery is even up to 70-80%. The pathogenesis of postoperative nausea and vomiting is very complex, including central, peripheral receptors and multiple nerve pathways. When peripheral receptors are stimulated, the signal passes through the afferent nerve to the vomiting center, causing nausea and vomiting. The emetic chemical receptors are rich in many receptors, which can directly feel various toxins, metabolites or drugs in the blood and cerebrospinal fluid, project signals to the nerve center and then spread to the cerebral cortex, causing nausea and vertigo, or transmit signals along the vagus nerve, glossopharyngeal nerve, spinal nerve, etc. to the digestive tract, diaphragm and abdominal wall muscles, resulting in the opening of the sphincter in the upper esophagus and strong contraction of the diaphragm. Abdominal muscles contract, so that the stomach pressure increases, stomach contents through the digestive tract is expelled from the body, vomiting.

Thyroid, as the endocrine organ of human body, mainly secretes thyroid hormone and participates in human metabolism. With the progress of modern medical technology, although thyroid postoperative complications have decreased, due to the limited operating space of thyroid surgery, in order to fully exposed the surgical field of vision and facilitate the operation of surgeons, patients often take the cervical hyperextension position, that is, patients take the supine position with high shoulder pads. Tilt your head back so that your lower jaw, trachea, and sternum are at the same level, allowing the thyroid gland to protrate forward as much as possible. Although this position is easy for surgeons to operate, due to the complex anatomical structure around the thyroid gland, adjacent to important blood vessels and nerves, this position often causes thyroid surgical position syndrome in patients, that is, nausea and vomiting, dizziness, headache, tinnitus, neck radiation pain and other symptoms, which not only increases patients' pain, but also seriously reduces patients' medical experience.

Stellate ganglion block has been proved to be widely used in clinic and can play a positive role in multiple organs and systems of the whole body. In clinical work, stellate ganglion block is more widely used in the treatment of various pain, autonomic nerve disorders and other diseases. However, there are few clinical studies on whether stellate ganglion block can be used as an effective and feasible means to prevent postoperative nausea and vomiting and the related mechanisms to prevent the possible occurrence of nausea and vomiting. Therefore, this study will explore the preventive effect of stellate ganglion block on postoperative thyroid nausea and vomiting, and hope to explore its possible mechanism, so as to provide more effective and feasible methods for clinical prevention of postoperative nausea and vomiting and improve patients' medical comfort and satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving thyroid surgery under general anesthesia
  • Age ≥18 years and ≤ 70 years
  • American Society of Anesthesiologists(ASA) physical status classification I-III.
  • Voluntary participation and ability to understand and sign the informed consent form.

排除标准

  • Patients with obesity(BMI>30 kg/m2)
  • contraindicated to stellate ganglion block
  • Patients who cannot cooperate with the study for any reason, or whom the investigator deems unsuitable for inclusion in this trial.

结局指标

主要结局

Incidence of Postoperative nausea and vomiting

时间窗: From end of surgery to 24 hours after surgery

Postoperative nausea and vomiting is evaluated by follow-up

次要结局

  • Intensity of nausea and vomiting during preemptive analgesia(From 0-10 min after preemptive analgesia)
  • Intensity of nausea and vomiting during hospitalization(From end of surgery to 24 hours after surgery)
  • Satisfaction score and postoperative analgesia satisfaction score(From end of surgery to hospital discharge with about 5 days)
  • Recovery of gastrointestinal function(From end of surgery to 24 hours after surgery)
  • Sleep quality(From end of surgery to 1 day after surgery)
  • Incidence of Postoperative nausea and vomiting during preemptive analgesia(From 0-10 min after preemptive analgesia)
  • Hemodynamic parameters after preemptive analgesia(From 0-10 min after preemptive analgesia)
  • Postoperative pain intensity(From end of surgery to 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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