The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- total
研究概览
简要总结
Laryngeal cancer is one of the most common tumors in otolaryngology. In China, it accounts for 1-5% of all malignancies and has an incidence of 1.13 per 100,000. Surgical resection is the most important treatment for patients who are not candidates for chemoradiotherapy or refuse chemoradiotherapy. The types of surgery include total and partial laryngectomy. Patients with laryngeal cancer often face multiple physical and psychiatric changes after surgery, such as daily large sputum production accompanied by cough, cleaning care of the air incision, fatigue, and sleep disturbances. Some patients do not actively exclude secretions due to pain, and the formation of sputum plugs causes lung inflammation, which is not conducive to postoperative recovery. Good postoperative pain management is beneficial to shorten the length of hospital stay and reduce mortality. Sufentanil is most commonly used for postoperative analgesia and has good analgesic effect, but there are some adverse effects, such as dizziness, nausea and vomiting, urinary retention, skin itching, respiratory depression, etc. As a new type of analgesic, dezocine has been widely used in clinical practice with few adverse reactions to the respiratory and circulatory system, and its application to postoperative analgesia can significantly improve the immune activity. At present, there are not many studies on continuous analgesia of dezocine, mostly single-dose analgesia studies, this study for different doses of dezocine for the postoperative analgesic effect of laryngeal cancer patients, compared with the current classic opioid analgesics, to provide a new scheme for clinical medication.
详细描述
Laryngeal cancer is one of the most common tumors in otolaryngology. In China, it accounts for 1-5% of all malignancies and has an incidence of 1.13 per 100,000. Surgical resection is the most important treatment for patients who are not candidates for chemoradiotherapy or refuse chemoradiotherapy. The types of surgery include total and partial laryngectomy. Patients with laryngeal cancer often face multiple physical and psychiatric changes after surgery, such as daily large sputum production accompanied by cough, cleaning care of the air incision, fatigue, and sleep disturbances. In patients with laryngeal cancer, large amounts of secretions can cause frequent coughing, even wheezing, and coughing can exacerbate the degree of postoperative pain. Some patients do not actively exclude secretions due to pain, and the formation of sputum plugs causes lung inflammation, which is not conducive to postoperative recovery. In addition, the inability to verbalize after laryngeal cancer surgery puts patients in a state of anxiety, which increases the degree of postoperative pain. Good postoperative pain management is beneficial to shorten the length of hospital stay and reduce mortality. Sufentanil is most commonly used for postoperative analgesia and has good analgesic effect, but there are some adverse effects, such as dizziness, nausea and vomiting, urinary retention, skin itching, respiratory depression, etc. As a new type of analgesic, dezocine has been widely used in clinical practice with few adverse reactions to the respiratory and circulatory system, and its application to postoperative analgesia can significantly improve the immune activity. At present, there are not many studies on continuous analgesia of dezocine, mostly single-dose analgesia studies, this study for different doses of dezocine for the postoperative analgesic effect of laryngeal cancer patients, compared with the current classic opioid analgesics, to provide a new scheme for clinical medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent elective partial laryngectomy
- •American society of Anesthesiologists (ASA) physical status classification :Ⅰ~Ⅱ
排除标准
- •chronic pain
- •long-term use of analgesics
- •allergy to perioperative medications
- •previous postoperative nausea and vomiting
研究组 & 干预措施
group S
sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Sufentanil injection (Drug)
group S
sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Flurbiprofen (Drug)
group S
sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Granisetron Injection (Drug)
group D1
dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Dezocine (Drug)
group D1
dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Flurbiprofen (Drug)
group D1
dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Granisetron Injection (Drug)
group D2
dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Dezocine (Drug)
group D2
dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Flurbiprofen (Drug)
group D2
dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg
干预措施: Granisetron Injection (Drug)
结局指标
主要结局
total
时间窗: from the end of the surgery to 48 hours after surgery
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
次要结局
- the incidence of nausea(from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours)
- 48 hours pressing times of Patient-controlled Analgesia(From the time of use postoperative analgesic to the time of 48 hours after the surgery)
- the incidence of respiratory depression(from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours)
- 24 hours amount of drug(From the time of use postoperative analgesic to the time of 24 hours after the surgery)
- Visual Analogue Scale(at the time of 48 hours after the surgery)
- the incidence of dizziness(from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours)
- the incidence of vomiting(from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours)
- the incidence of urinary(from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours)