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临床试验/NCT03276533
NCT03276533已完成不适用

Effects of Intravenous Dexmedetomidine, Lidocaine and Their Combination on Postoperative Inflammation Cytokines After Laparoscopic Hysterectomy With General Anesthesia

Anqing Municipal Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年11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
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

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

Experimental

干预措施: Saline (Drug)

Intravenous saline, dexmedetomidine and lidocaine

Experimental

干预措施: Lidocaine (Drug)

Intravenous saline, dexmedetomidine and lidocaine

Experimental

干预措施: Dexmedetomidine (Drug)

Intravenous saline, dexmedetomidine and lidocaine

Experimental

干预措施: Lidocaine plus Dexmedetomidine (Drug)

Intravenous saline, dexmedetomidine, lidocaine and combination

Experimental

干预措施: Saline (Drug)

Intravenous saline, dexmedetomidine, lidocaine and combination

Experimental

干预措施: Lidocaine (Drug)

Intravenous saline, dexmedetomidine, lidocaine and combination

Experimental

干预措施: Dexmedetomidine (Drug)

Intravenous saline, dexmedetomidine, lidocaine and combination

Experimental

干预措施: Lidocaine plus Dexmedetomidine (Drug)

Intravenous saline,dexmedetomidine plus lidocaine

Experimental

干预措施: Saline (Drug)

Intravenous saline,dexmedetomidine plus lidocaine

Experimental

干预措施: Lidocaine (Drug)

Intravenous saline,dexmedetomidine plus lidocaine

Experimental

干预措施: Dexmedetomidine (Drug)

Intravenous saline,dexmedetomidine plus lidocaine

Experimental

干预措施: Lidocaine plus Dexmedetomidine (Drug)

Intravenous saline, dexmedetomidine combined with lidocaine

Experimental

干预措施: Saline (Drug)

Intravenous saline, dexmedetomidine combined with lidocaine

Experimental

干预措施: Lidocaine (Drug)

Intravenous saline, dexmedetomidine combined with lidocaine

Experimental

干预措施: Dexmedetomidine (Drug)

Intravenous saline, dexmedetomidine combined with lidocaine

Experimental

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

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

Xu Siqi

Principal Investigator,Department of Anesthesiology

Anqing Municipal Hospital

研究点 (1)

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