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临床试验/NCT01839253
NCT01839253已完成不适用

The Effect of Antihypertensive Agents Concerning With Hemodynamics and Reduction of Anaesthetics in Orthognathic Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2012年8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
状态
已完成
入组人数
75
试验地点
1
主要终点
the influence of antihypertensive agents on hemodynamic stability

研究概览

简要总结

For those who receive hypotensive anesthesia in orthognathic surgeries, the investigators premedicate with anti-hypertensive agent so that it decreases the occurence of tachycardia and the rebound hypertension due to hypotensive anesthesia, enabling us to compare hemodynamic stability and reduction of anesthetic agents during the operation.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA class I-II
  • obtaining written informed consent from the parents
  • aged 18-29 years who were undergoing orthognathic surgery.

排除标准

  • Hypertension patients with anti-hypertensive agents
  • chronic renal failure or End stage renal disease patients.
  • renal artery stenosis history.
  • Patients who are with medication due to systemic disease.
  • symptomatic asthma
  • Drug hyperactivity
  • neurological or psychiatric illnesses
  • mental retardation
  • patients who can't read the consent form due to illiterate or foreigner

研究组 & 干预措施

Atenolol

Experimental

In each group, premedication with either b-blocker (Atenolol) or ACE inhibitor (enalapril) or nothing (control group) in the preparation room.

干预措施: b-blocker(Atenolol) (Drug)

Enalapril

Active Comparator

In each group, premedication with either b-blocker (Atenolol) or ACE inhibitor (enalapril) or nothing (control group) in the preparation room.

干预措施: ACE inhibitor(Enapril) (Drug)

control

Placebo Comparator

none of antihypertensive agents

干预措施: control (Other)

结局指标

主要结局

the influence of antihypertensive agents on hemodynamic stability

时间窗: From the beginning until the end of hypoetensive anesthesiaan expected average of 65 mins.(From manipulration of Mandible to maxilla)

Total minutes when the MAP is lower than 55mmHg and higher than 65mmHg (min) , The time below 55 mmHg(min) , The total time above 65 mmHg (min) Total remifentanil amount, total NTG amount, total phenylephrine amount Arterial gas analysis 4 times after induction, at the start of manipulation of mandible, at the start of manipulation of maxilla, at the end of surgery. Pr-operative and post-operative lab (Hb, Bun, Cr, OT, PT, Na, K) Intraoperative total fluid, total urine amount, total blood loss, transfusion amount.

次要结局

  • reduction of anaesthetics with control(From the beginning until the end of hypoetensive anesthesia an expected average of 65 mins.(From manipulration of Mandible to maxilla))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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