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临床试验/NCT04706767
NCT04706767已完成不适用

Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy

Anqing Municipal Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年1月28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
Quality of recovery scores(QoR-40)

研究概览

简要总结

BACKGROUND: Some studies have revealed that intravenous (IV) lidocaine or dexmedetomidine might improve the quality of recovery undergoing laparoscopic surgery. The investigators investigated whether co-administration lidocaine and dexmedetomidine could better improve the the quality of recovery after laparoscopic total hysterectomy.

METHODS: One hundred and forty-four women with elective laparoscopic total hysterectomy were randomly divided into four groups: Patients in group L received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close the pneumoperitoneum. Patients in group D received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close the pneumoperitoneum. Patients in group LD received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close the pneumoperitoneum, respectively. Patients in group C received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close the pneumoperitoneum. Primary outcome was the quality of recovery (QoR-40) at 1 day prior to sugery, 1 day after sugery, and 2 days after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS scores, the incidence of postoperative nausea and vomiting, postoperative rescue analgesics and anti-emetics, recovery time, extubation time, and Ramsay sedation scale at 5 min, 10min, 30 min, 60 min after extubation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
  • Scheduled for elective laparoscopic total 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

研究组 & 干预措施

Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery

Experimental

干预措施: Co-administration Lidocaine and Dexmedetomidine (Drug)

Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery

Experimental

干预措施: Dexmedetomidine infusion (Drug)

Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery

Experimental

干预措施: Lidocaine infusion (Drug)

Effect of Dexmedetomidine infusion on Quality of Recovery

Experimental

干预措施: Dexmedetomidine infusion (Drug)

Effect of saline infusion on Quality of Recovery

Experimental

干预措施: Saline infusion (Drug)

Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery

Experimental

干预措施: Saline infusion (Drug)

Effect of Dexmedetomidine infusion on Quality of Recovery

Experimental

干预措施: Co-administration Lidocaine and Dexmedetomidine (Drug)

Effect of Dexmedetomidine infusion on Quality of Recovery

Experimental

干预措施: Lidocaine infusion (Drug)

Effect of Dexmedetomidine infusion on Quality of Recovery

Experimental

干预措施: Saline infusion (Drug)

Effect of Lidocaine infusion on Quality of Recovery

Experimental

干预措施: Co-administration Lidocaine and Dexmedetomidine (Drug)

Effect of Lidocaine infusion on Quality of Recovery

Experimental

干预措施: Dexmedetomidine infusion (Drug)

Effect of Lidocaine infusion on Quality of Recovery

Experimental

干预措施: Lidocaine infusion (Drug)

Effect of Lidocaine infusion on Quality of Recovery

Experimental

干预措施: Saline infusion (Drug)

Effect of saline infusion on Quality of Recovery

Experimental

干预措施: Co-administration Lidocaine and Dexmedetomidine (Drug)

Effect of saline infusion on Quality of Recovery

Experimental

干预措施: Dexmedetomidine infusion (Drug)

Effect of saline infusion on Quality of Recovery

Experimental

干预措施: Lidocaine infusion (Drug)

结局指标

主要结局

Quality of recovery scores(QoR-40)

时间窗: 1 day after operation

Our primary outcome was Quality of recovery scores(QoR-40) 1 day after operation

次要结局

  • Intraoperative remifentanil total dose(Intraoperative)
  • Pain visual analogue scale scores(The first 24 hours after operation)
  • The length of post-anesthesiacare unit stay(Immediately after the surgery)
  • Recovery time(Immediately after the surgery)
  • The consumption of sufentanil(The first 24 hours after operation)
  • Extubation time(Immediately after the surgery)
  • PONV scores(The first 24 hours after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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