Effects of Intravenous Dexmedetomidine, Lidocaine and Their Combination on Postoperative Inflammation Cytokines After Laparoscopic Hysterectomy With General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Interleukin-6
研究概览
简要总结
Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic hysterectomy.
Methods: Investigators enrolled 160 women with American Society of Anesthesiologists (ASA) physical status I and II, aged 40-65 years, and scheduled for elective laparoscopic hysterectomy with general anesthesia from October 2017 to August 2018. The participants were randomly assigned into four groups(n=40 each group): group CON received normal saline infusion, group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion), group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and group LIDO+DEX received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). The four groups received an IV bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine until abdominal wound closure, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), the end of surgery (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status I and II
- •weighted 50 kg-65 kg
- •aged 40-65 yr
- •elective laparoscopic hysterectomy with general anesthesia
排除标准
- •a history of allergy to local anesthetics
- •severe respiratory, renal or hepatic disease
- •preoperative opioids medication
- •psychiatric medical history
- •Patients with severe hypotension [mean arterial pressure (MAP<60 mmHg)] or bradycardia [heart rate (HR) <40 beats per minute (bpm)], arrhythmia, or urticaria due to lidocaine and dexmedetomidine infusion during the surgery
研究组 & 干预措施
Intravenous saline, dexmedetomidine and lidocaine
干预措施: Saline (Drug)
Intravenous saline, dexmedetomidine and lidocaine
干预措施: Lidocaine (Drug)
Intravenous saline, dexmedetomidine and lidocaine
干预措施: Dexmedetomidine (Drug)
Intravenous saline, dexmedetomidine and lidocaine
干预措施: Lidocaine plus Dexmedetomidine (Drug)
Intravenous saline, dexmedetomidine, lidocaine and combination
干预措施: Saline (Drug)
Intravenous saline, dexmedetomidine, lidocaine and combination
干预措施: Lidocaine (Drug)
Intravenous saline, dexmedetomidine, lidocaine and combination
干预措施: Dexmedetomidine (Drug)
Intravenous saline, dexmedetomidine, lidocaine and combination
干预措施: Lidocaine plus Dexmedetomidine (Drug)
Intravenous saline,dexmedetomidine plus lidocaine
干预措施: Saline (Drug)
Intravenous saline,dexmedetomidine plus lidocaine
干预措施: Lidocaine (Drug)
Intravenous saline,dexmedetomidine plus lidocaine
干预措施: Dexmedetomidine (Drug)
Intravenous saline,dexmedetomidine plus lidocaine
干预措施: Lidocaine plus Dexmedetomidine (Drug)
Intravenous saline, dexmedetomidine combined with lidocaine
干预措施: Saline (Drug)
Intravenous saline, dexmedetomidine combined with lidocaine
干预措施: Lidocaine (Drug)
Intravenous saline, dexmedetomidine combined with lidocaine
干预措施: Dexmedetomidine (Drug)
Intravenous saline, dexmedetomidine combined with lidocaine
干预措施: Lidocaine plus Dexmedetomidine (Drug)
结局指标
主要结局
Interleukin-6
时间窗: postoperative 24 hours
Interleukin-6 level in serum was measured at the before administration of drugs (T1), Interleukin-6 level in serum was measured at the end of the operation (T2); Interleukin-6 level in serum was measured at the postoperative 2 hour (T3); Interleukin-6 level in serum was measured at the postoperative 24 hour (T4)
Tumor necrosis factor-α
时间窗: postoperative 24 hours
Tumor necrosis factor-α level in serum was measured at the before administration of drugs (T1); Tumor necrosis factor-α level in serum was measured at the end of the operation (T2); Tumor necrosis factor-α level in serum was measured at the postoperative 2 hour (T3); Tumor necrosis factor-α level in serum was measured at the postoperative 24 hour (T4)
Interleukin-1
时间窗: postoperative 24 hours
Interleukin-1 level in serum was measured at the before administration of drugs (T1); Interleukin-1 level in serum was measured at the end of the operation (T2); Interleukin-1 level in serum was measured at the postoperative 2 hour (T3); Interleukin-1 level in serum was measured at the postoperative 24 hour (T4)
次要结局
未报告次要终点
研究者
Xu Siqi
Principal Investigator,Department of Anesthesiology
Anqing Municipal Hospital
