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临床试验/NCT05899127
NCT05899127招募中4 期

Effects of Intravenous Lidocaine Infusion on Stress Response in Patients Undergoing Abdominal Surgery During Perioperative Anesthesia and Its Correlation With Serum Orphanin FQ (N/OFQ)

Second Hospital of Shanxi Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年7月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Serum Norepinephrine

研究概览

简要总结

The intravenous injection of lidocaine during the perioperative period has been widely used in various types of surgeries. Its clinical effect includes reducing stress response during anesthesia, decreasing pain and opioid consumption, lowering the incidence of postoperative nausea, vomiting, cognitive dysfunction, and reducing the injection pain of propofol. However, despite the positive impact of lidocaine on surgical patients, its mechanism of action remains unclear. Serum N/OFQ is a neurotransmitter that plays an important role in regulating pain and emotion. Therefore, this study aims to explore the effects of perioperative intravenous injection of lidocaine on stress responses in surgical patients, as well as its mechanism of action, and whether Serum N/OFQ participates in this process.

详细描述

We hypothesize that intravenous injection of lidocaine during the perioperative period can reduce expression of endogenous opioid peptides, which in turn can decrease secretion of IL-6 and TNF-α, ultimately leading to a reduction in perioperative stress response. This randomized controlled trial will be conducted at the Second Hospital of Shanxi Medical University in China, with the aim of observing changes in stress-related indicators (blood pressure, heart rate, heart rate variability, IL-6, TNF-α, as well as Serum N/OFQ ) between patients undergoing abdominal surgery under total intravenous general anesthesia with and without lidocaine injection. Lidocaine will be administered as a loading dose during anesthesia induction and continued via infusion until the end of anesthesia maintenance, with appropriate depth of anesthesia or BIS readings utilized for monitoring anesthesia depth. Routine monitoring parameters, including blood pressure, heart rate, SpO2, and electrocardiogram, will be recorded and analyzed. Blood samples will be collected 30 minutes before anesthesia induction, 1 minute after tracheal intubation, and at the end of surgery. The use of lidocaine will be evaluated for its impact on perioperative stress response in patients undergoing abdominal surgery, with the relationship to changes in levels of endogenous opioid peptides explored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients undergoing elective abdominal surgery with anesthesia duration less than 1-2h

排除标准

  • It is estimated that patients with difficulty in tracheal intubation (poor head and neck mobility, history of airway surgery, history of OSAHS, nail to chin distance<6cm, Malampati grade 3 and above, mouth opening<2.5cm, obesity (BMI>30kg · m-2), etc.)
  • Hypertension patients (clinically diagnosed as hypertension), coronary heart disease patients (with typical symptoms of angina pectoris and exclusion of aortic valve disease, clear history of old myocardial infarction, clear history of acute myocardial infarction)
  • Patients with diabetes and central nervous system diseases
  • Patients with long-term use of sedatives or antidepressants
  • Patients with a history of alcoholism or drug dependence
  • Asthma or reactive airway disease
  • Shock, severe hypotension, severe arrhythmia and other adverse events occurred during the operation

研究组 & 干预措施

Lidocaine

Experimental

Lidocaine will be injected intravenously at 1.5mg/kg during anesthesia induction and intravenously pumped at 1.5mg/kg/h during anesthesia induction.

干预措施: Lidocaine (Drug)

Control group

Placebo Comparator

Normal saline will be injected intravenously at 1.5mg/kg during the induction period and intravenously pumped at 1.5mg/kg/h during the induction period.

干预措施: 0.9%NaCl (Drug)

结局指标

主要结局

Serum Norepinephrine

时间窗: 24 hours

It may have been involved in the regulation of stress response processes by lidocaine.

Stress response index

时间窗: 24 hours

It includes blood pressure, heart rate, heart rate variability,IL-6 and TNF-α.

次要结局

未报告次要终点

研究者

发起方
Second Hospital of Shanxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zheng Guo

Professor

Second Hospital of Shanxi Medical University

研究点 (1)

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