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临床试验/NCT04409964
NCT04409964已完成不适用

the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy

The Catholic University of Korea1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020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
78
试验地点
1
主要终点
the quality of recovery

研究概览

简要总结

This study is performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy.

详细描述

The quality of recovery after the surgery is assessed using the QoR 40. In addition, the various kinds of cytokine are assessed for the ancillary study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patient scheduled for gynecological laparoscopic surgery

排除标准

  • refusal to participate in this study
  • emergent surgery
  • chronic pain requiring for pain killer
  • psychiatric disease
  • preoperative bradycardia or hypotension
  • allergy or history of the adverse effect to study drug
  • pregnancy or lactation

研究组 & 干预措施

opioid-free anesthesia

Experimental

The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.

干预措施: Dexmedetomidine Hydrochloride (Drug)

opioid-free anesthesia

Experimental

The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.

干预措施: Lidocaine Hydrochloride (Drug)

opioid anesthesia

Active Comparator

The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy.

干预措施: Remifentanil Hydrochloride (Drug)

结局指标

主要结局

the quality of recovery

时间窗: at 24 hour after the completion of surgery

The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery.

次要结局

  • cytokine(during surgery)

研究者

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

Young Eun Moon

associate professor

The Catholic University of Korea

研究点 (1)

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