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临床试验/NCT03809923
NCT03809923已完成不适用

Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia

Anqing Municipal Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019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
状态
已完成
入组人数
240
试验地点
1
主要终点
postoperative nausea

研究概览

简要总结

BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine decreased the incidence of postoperative nausea and vomiting (PONV). The investigators investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the incidence of PONV after laparoscopic hysterectomy.

METHODS: Two hundred and forty women with elective laparoscopic hysterectomy were randomly divided into four groups: the control group (group C, n=60) received an equal volume of saline, the lidocaine group (group L, n=60) received IV lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion), the dexmedetomidine group (group D, n=60) received dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion), the lidocaine plus dexmedetomidine group (group LD, n=60) received combination of lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion) and dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion). Primary outcome was the incidence of the first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
  • Aged 40-60 years
  • Scheduled for elective laparoscopic hysterectomy

排除标准

  • History of allergy to local anesthetics
  • Severe respiratory disease
  • Renal or hepatic insufficiency
  • History of preoperative opioids medication and psychiatric
  • preoperative bradycardia
  • preoperative atrioventricular block
  • Subjects who experienced severe hypotension (mean arterial pressure [MAP] <60 mmHg) or bradycardia (heart rate [HR] <40 bpm), urticaria, or arrhythmia during lidocaine and dexmedetomidine infusion period

研究组 & 干预措施

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

Experimental

干预措施: lidocaine and dexmedetomidine infusion (Drug)

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

Experimental

干预措施: Saline infusion (Drug)

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

Experimental

干预措施: Lidocaine infusion (Drug)

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

Experimental

干预措施: Dexmedetomidine infusion (Drug)

Effect of infusion saline on PONV

Experimental

干预措施: lidocaine and dexmedetomidine infusion (Drug)

Effect of infusion saline on PONV

Experimental

干预措施: Saline infusion (Drug)

Effect of infusion saline on PONV

Experimental

干预措施: Lidocaine infusion (Drug)

Effect of infusion saline on PONV

Experimental

干预措施: Dexmedetomidine infusion (Drug)

Effect of infusion lidocaine on PONV

Experimental

干预措施: lidocaine and dexmedetomidine infusion (Drug)

Effect of infusion lidocaine on PONV

Experimental

干预措施: Saline infusion (Drug)

Effect of infusion lidocaine on PONV

Experimental

干预措施: Lidocaine infusion (Drug)

Effect of infusion lidocaine on PONV

Experimental

干预措施: Dexmedetomidine infusion (Drug)

Effect of infusion dexmedetomidine on PONV

Experimental

干预措施: lidocaine and dexmedetomidine infusion (Drug)

Effect of infusion dexmedetomidine on PONV

Experimental

干预措施: Saline infusion (Drug)

Effect of infusion dexmedetomidine on PONV

Experimental

干预措施: Lidocaine infusion (Drug)

Effect of infusion dexmedetomidine on PONV

Experimental

干预措施: Dexmedetomidine infusion (Drug)

结局指标

主要结局

postoperative nausea

时间窗: 24-48 hours after surgery

Our primary outcome was the incidence of nausea during the 24-48 hours after surgery

postoperative vomiting

时间窗: 24-48 hours after surgery

Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery

postoperative nausea and vomiting (PONV)

时间窗: 24-48 hours after surgery

Our primary outcome was the incidence of PONV during the 24-48 hours after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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