跳至主要内容
临床试验/NCT04922359
NCT04922359Unknown不适用

Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults: a Multicenter, Randomized, Double-blind, Controlled Study

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
96
试验地点
1
主要终点
First anal exhaust time

研究概览

简要总结

Spinal surgery often involves multiple segments. The trauma of surgery is large, the duration of postoperative pain is long, and the pain is severe. Therefore, the use of opioids in perioperative period is large. Although the application of * large amounts of opioids can effectively inhibit pain, it will delay the recovery of urine retention, sedation, respiratory depression and gastrointestinal function. The delayed recovery of gastrointestinal function will increase the postoperative complications, and then increase the length of hospital stay and the cost of patients. Therefore, reducing the dosage of opioids to promote the recovery of gastrointestinal function has become the research direction. Intravenous lidocaine has been proved to be effective in reducing the dosage of opioids during the perioperative period of gastrointestinal surgery and promoting the recovery of postoperative gastrointestinal function. However, there are few studies on the application of lidocaine during the perioperative period of spinal surgery, especially the impact on postoperative gastrointestinal function. In this study, a multicenter, randomized, double-blind, controlled study was conducted to explore the effect of perioperative lidocaine on the recovery of gastrointestinal function after adult lumbar surgery. We hypothesized that lidocaine could shorten the recovery time of gastrointestinal function after lumbar surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 60 to 80;
  • ASA physical status score of I, II or III;
  • Scheduled to undergo a posterior lumbar surgery;
  • Ideal body weight≤80 kg;

排除标准

  • Those who are refused to be included;
  • Those who are allergic to the drugs used in this study;
  • Emergency operation
  • Degree II or III atrioventricular block
  • heart failure
  • History of ALS, preexcitation or active dysrhythmia
  • Severe liver injury (bilirubin > 1.46 mg/dl)
  • Severe renal injury (creatinine clearance < 30 ml/min) or Renal failure
  • History of epilepsy
  • History of porphyria
  • Preoperative hypotension (SBP< 90mmHg)
  • Drug contraindications of NSAIDs
  • Allergic to anaesthetic

研究组 & 干预措施

Experimental: Lidocaine group

Experimental

干预措施: Lidocain (Drug)

Placebo Comparator: comparator group

Placebo Comparator

干预措施: normal saline (Drug)

结局指标

主要结局

First anal exhaust time

时间窗: Day 0

Time of first anal exhaust after operation

次要结局

  • First diet time(Day 0)
  • First defecation time(Day 0)
  • Time to get out of bed(Day 0)

研究者

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

Yi Feng, MD

Head of Anesthesiology

Peking University People's Hospital

研究点 (1)

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