跳至主要内容
临床试验/NCT03643796
NCT03643796已完成4 期

The Effect of a Narcotic Free Total Intravenous Anesthesia on the Outcome and Patient Safety During Anterior Cervical Discectomy and Fusion (ACDF) Surgery: A Randomized Controlled Trial

University of Arkansas1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
32
试验地点
1
主要终点
Incidence of Unacceptable Movement Under General Anesthesia

研究概览

简要总结

This study will help the investigators learn more about the best way to give anesthesia for these kinds of surgery. The investigators will be using 2 different groups of medications that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does not. The investigators wish to test whether a narcotic free anesthetic will result in an overall safer surgery, better patient recovery, and satisfaction. The investigators think also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover faster after surgery , and consume less pain medicines in the postoperative period.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Remifentanil Group

Active Comparator

Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.

干预措施: Remifentanil (Drug)

Ketamine and Dexmedetomidine group

Active Comparator

dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.

Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.

干预措施: Ketamine (Drug)

Ketamine and Dexmedetomidine group

Active Comparator

dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.

Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Incidence of Unacceptable Movement Under General Anesthesia

时间窗: duration of surgery

Gross visible movement reported by the anesthesiologist or surgical team: bucking, chewing, or reaching to the endotracheal tube and induced by nociception, or head manipulation and positioning by the surgical or anesthesiology team or during a motor evoked potential stimulation.

次要结局

  • Hemodynamic Stability(up to 24 hours)
  • Time to Extubation(up to 24 hours)
  • Narcotic Consumption(24 hours)
  • Quality of Recovery(24 hours post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验