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临床试验/NCT03468062
NCT03468062Unknown4 期

The Effect of Preoperative Intravenous Dexmedetomidine on Postoperative Quality of Recovery: Randomized Study

Kyungmi Kim1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年5月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
Kyungmi Kim
入组人数
90
试验地点
1
主要终点
Quality of recovery questionnaire

研究概览

简要总结

Dexmedetomidine is a selective a2-agonist and a sedative with anti-inflammatory,analgesic, and antiemetic effects, and its use for procedural sedation during endoscopy or ablation for atrial fibrillation has been increasing. It is also used for sedation in the intensive care unit. Recently, it was reported that dexmedetomidine is often used as an adjuvant for general anesthesia. Sympatholysis of dexmedetomidine can attenuate the increased sympathetic tone after surgery and result in antistress effects. In addition, opioid-sparing and analgesic effects are promoted by the perioperative administration of dexmedetomidine. Although it has been reported that the perioperative administration of dexmedetomidine improves quality of recovery after spinal and ENT surgeries, the outcomes for patients who undergo laparoscopic cholecystectomy remain poorly investigated.

The aims of this study were to evaluate the effects of preoperative dexmedetomidine administration on quality of recovery by using the QoR-40 questionnaire in patients who undergo laparoscopic cholecystectomy.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients who undergo elective cholecystectomy
  • Adults (20~75 years old)
  • an American Society of Anesthesiologists physical status of I or II

排除标准

  • The patients do not provide written informed consent
  • The patients have had allergic response to dexmedetomidine.
  • The patients have mood disorder or anxiety disorder.
  • The patients are not able to express their emotions.
  • The pregnant women

研究组 & 干预措施

Dexmedetomidine

Experimental

0.5 mg/kg of dexmedetomidine (Precedex; Hospira, Lake Forest, IL) is mixed in normal saline 100mL and administered for 5 minutes after anesthetic induction.

干预措施: Dexmedetomidine (Drug)

Placebo

Placebo Comparator

Only normal saline 100mL is administered for 5 minutes after anesthetic induction.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Quality of recovery questionnaire

时间窗: postoperative first day

The Quality of Recovery questionnaire (QoR-40) is a tool used to assess the quality of recovery after surgery through questions pertaining to 40 items related to 5 domains. It has been validated as a global and reliable measurement tool.

次要结局

未报告次要终点

研究者

发起方
Kyungmi Kim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kyungmi Kim

Assistant Professor

Gachon University Gil Medical Center

研究点 (1)

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