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临床试验/NCT03076099
NCT03076099Unknown不适用

Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization

Nan Jiang1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1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
发起方
入组人数
30
试验地点
1
主要终点
urapidil consumption

研究概览

简要总结

Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.

详细描述

Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

this investigation is a triple mask study. The patiens, the care providers and Outcome Assessor will not allowed to know the grouping information.

入排标准

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

入选标准

  • patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.

排除标准

  • abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.

研究组 & 干预措施

Dexmedetomidine

Experimental

Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.

干预措施: Dexmedetomidine (Drug)

Control group

Placebo Comparator

Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.

干预措施: normal saline (Other)

结局指标

主要结局

urapidil consumption

时间窗: the end of the 6th hour after tracheal extubation

urapidil consumption was recorded by nurses every hour

次要结局

  • Quality of Recovery Score(the end of the 6th hour after tracheal extubation)
  • urapidil consumption on POD1(the total consumption of urapidil on post-operative day 1.)
  • Quality of Recovery Score at 48th hour(the end of the 48th hour after tracheal extubation)
  • Bradycardia(the end of the 6th hour after tracheal extubation)
  • PONV(the end of the 6th hour after tracheal extubation)
  • Visual Analogue score at 48th hour(the end of the 48th hour after tracheal extubation)
  • Analgesics consumption on POD1(the total consumption of urapidil on post-operative day 1.)
  • Bradycardia at 48th hour(the end of the 48th hour after tracheal extubation)
  • PONV at 24th hour(the end of the 24th hour after tracheal extubation)
  • urapidil consumption on POD2(the total consumption of urapidil on post-operative day 2.)
  • Visual Analogue score(the end of the 6th hour after tracheal extubation)
  • Visual Analogue score at 24th hour(the end of the 24th hour after tracheal extubation)
  • Quality of Recovery Score at 24th hour(the end of the 24th hour after tracheal extubation)
  • Bradycardia at 24th hour(the end of the 24th hour after tracheal extubation)
  • Analgesics consumption(the end of the 6th hour after tracheal extubation)
  • Analgesics consumption on POD2(the total consumption of urapidil on post-operative day 2.)
  • PONV at 48th hour(the end of the 48th hour after tracheal extubation)

研究者

发起方
Nan Jiang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nan Jiang

associate professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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