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临床试验/NCT02819089
NCT02819089Unknown不适用

Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant

Mahidol University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Riker sedation agitation scores

研究概览

简要总结

The purpose of this study is to determine the recovery profiles after general anesthesia in patient undergoing anterior cervical spine surgery. This study will compare the Riker sedation agitation scores between two groups, with or without dexmedetomidine as an anesthetic adjuvant.

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

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective case for ACDF surgery
  • plan for extubation after surgery

排除标准

  • SBP>140 mmHg
  • HR<50 BPM, heart block
  • motor weakness > grade 4
  • allergic to dexmedetomidine, fentanyl

研究组 & 干预措施

Dexmedetomidine

Active Comparator

Demedetomidine infusion (2mcg/ml); loading 0.5 mcg/kg for 30 min (BW/2 ml/h for 30 min), then 0.5 mcg/kg (BW/4 ml/h) until 30 minutes before finish the operation.

干预措施: Dexmedetomidine (Drug)

NSS

Placebo Comparator

NSS loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.

干预措施: NSS (Other)

结局指标

主要结局

Riker sedation agitation scores

时间窗: before extubation

After finish the operation, Desflurane will be stopped. All patients will be received the neuromuscular reversal drugs and TOF ratio \> 0.9. All patients will be evaluated by Riker sedation agitation score before extubation and re-evaluated again at 15 minutes after extubation. Riker sedation agitation scores 1. Dangerous agitation: trying to get out of bed, pulling out tube, thrashing 2. Very agitated: may require physical restraint, unable to calm with verbal instructions. 3. Agitated: mild agitation and anxiety but calm down with verbal instructions. 4. Calm and cooperative: aroused easily and follows commands 5. Sedated: difficult to aroused, but does arouse to verbal or physical stimuli, able to follow simple commands 6. Very sedated: does not follow commands but arouses to physical stimulation 7. Unarousable: little or no response to noxious stimuli

次要结局

  • Fentanyl consumption(during surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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