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临床试验/NCT06238011
NCT06238011尚未招募不适用

Effect of Dexmedetomidine on Attenuation Hemodynamic Response in Coronary Artery Bypass Graft Surgical Patients: A Randomized Double Blind Controlled Trial

Sawanpracharak hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月28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
状态
尚未招募
入组人数
60
试验地点
1
主要终点
heart rate, blood pressure(systolic blood pressure, diastolic blood pressure, mean blood pressure)

研究概览

简要总结

Aim to study efficacy of dexmedetomidine to attenuate hemodynamic response to intubation, skin incision, sternotomy and aortic cannulation

详细描述

A randomized controlled trial was conduct between January2024 and March2024 at Sawanpracharak hospital, Thailand. Of 60 patients undergoing elective coronary artery bypass graft, 30 were assigned to group dexmedetomidine and 30 to group control. Dexmedetomidine prepared by anesthetist nurse in concentration 0.1 microgram/kg/ml total volume 50 ml. loading dose 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass (loading dose 1 microgram/kg for 10 minutes then 0.5 microgram/kg/hour). Group control receive normal saline 60ml/hour for 10minutes then 5 ml/hour

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 (Investigator)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients schedule for CABG
  • American Society of Anesthesiologist (ASA) class II-III

排除标准

  • anticipated difficult intubation
  • body mass index> 30 kg/m2
  • Ejection Fraction < 40%
  • left main coronary artery occlusion >50%
  • left bundle branch block
  • severe valvular heart disease
  • severe pulmonary, renal, hepatic disease
  • neurologic disease
  • preoperative medication with methyldopa or clonidine

研究组 & 干预措施

Dexmedetomidine

Active Comparator

Patient in this arm will receive dexmedetomidine loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass

干预措施: Dexmedetomidine (Drug)

Normal Saline

Placebo Comparator

Patient in this arm will receive normal saline loading 60ml/hour before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary artery bypass

干预措施: Normal saline (Drug)

结局指标

主要结局

heart rate, blood pressure(systolic blood pressure, diastolic blood pressure, mean blood pressure)

时间窗: during surgery

1. heart rate in beat per minute 1.1just after loading dose 1.2 before intubation 1.3at1,3,5 minute after intubation 1.4 before skin incision 1.5 1,3,5 minutes after skin incision 1.6 before sternotomy 1.7 1,3,5 minutes after sternotomy 2. Blood pressure (SBP, DBP,MAP)in mmHg 2.1 just after loading dose 2.2 before intubation 2.3 1,3,5 minutes after intubation 2.4 before skin incision 2.5 1,3,5 minute after skin incision 2.6 before sternotomy 2.7 1,3,5 minutes after sternotomy

次要结局

  • dose nicardipine(pre- aortic cannulation period , during surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Padet Boonmark

Clinician at Department of Anesthesiology

Sawanpracharak hospital

研究点 (1)

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