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临床试验/NCT03477994
NCT03477994已完成不适用

Efficacy of Dexmedetomidine Versus Clonidine to Control Delirium in Patients Undergoing Coronary Artery Bypass Grafting

Ain Shams University1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2018年12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
状态
已完成
入组人数
147
试验地点
1
主要终点
the incidence of delirium

研究概览

简要总结

This prospective, randomised, double blinded, controlled clinical trial will be conducted in 147 patients between 60 yr and 70 yr , ASA physical status II and III, undergoing CABG. Patients will be randomly allocated to either dexmedetomidine or clonidine (control) groups .Upon arrival to ICU, in the dexmedetomidine group, patients will receive an infusion of 0.5-0.7 μg/kg/h then 1.4 μg/kg/h if Richmond assessment sedation score from +1 to +4

Taking into consideration if the heart rate less than 60 per minute or persistent hypotension reduce infusion rate by 0.2 μg/kg/h.

Once the patient will be extubated, wean the infusion by 0.1μg/kg/h till reaching 0.2μg/kg/h. Slow the weaning rate if evidence of withdrawal reactions as agitation or hypertension occur. In clonidine group, the patients will receive 0.5μg/kg then 0.1-0.2 μg/kg/h.Primary end point of the study is the incidence of delirium.The secondary endpoints will be the the duration of extubation, the length of ICU stay, need for inotropic support or vasopressors, hospital stay , mean arterial blood pressure and heart rate , hospital mortality rate , all additional sedatives including overall doses of morphine and haloperidol the incidence of adverse events as bradycardia

详细描述

After Ethics committee approval, and a written informed consent will be taken from every patient, . Patients with a history of mental illness, severe dementia, delirium or undergoing emergency procedures will be excluded.

Anesthesia management will be standardized to minimize any effect of anesthetic type on neurological outcomes. Premedication with midazolam will be limited to a maximum of 0.05 mg/kg.

Anesthesia will be induced with 12 μg/kg fentanyl, 5-7mg/kg thiopental sodium, and 0.15 mg/kg pancuronium and maintained with 1% to 2.0% isoflurane. The heart rate and blood pressure will be maintained within 20% of the baseline values. Anticoagulation will be achieved with heparin to maintain an activated clotting time above 480 s.The CPB circuit will be primed with 1.8 l lactated Ringer's solution and 50 ml of 20% mannitol. Management of CPB will include systemic temperature drift to 32 C, targeted mean perfusion pressure between 60 and 80 mmHg, and pump flow rates of 2.2 l/min/m2 . Myocardial protection will be achieved with antegrade cold blood cardioplegia. A 32-μ m filter (Avecor Affinity, USA)will be used in the arterial perfusion line. Before separation from CPB, patients will be rewarmed to 36 to 37C. After separation from CPB, heparin will be neutralized with protamine sulfate, 1 mg/100 U heparin, to reach an activated clotting time within 10% of baseline.All patients will be transferred to ICU after surgery. Patients will be randomly allocated to either dexmedetomidine or clonidine (control) groups according to a computer-generated randomization code, with allocation ratio 1:1 .Opaque sealed envelopes will be done according to the randomization schedule and opened by a physician not involved in the study . Upon arrival to ICU, in the dexmedetomidine group, patients will receive an infusion of 0.5-0.7 μg/kg/h then 1.4 μg/kg/h if Richmond assessment sedation score from +1 to +4

+4 Combative ,+3 Very agitated ,+2 Agitated,+1 Restless, 0 Alert and calm, -1 Drowsy , -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarrousable A four millilitres vial of dexmedetomidine ( 100 micrograms per ml)will be drawn up and diluted in 46 ml of normal saline.The infusion of dexmedetomidine will be continued for a maximum period of 24 h. Taking into consideration if the heart rate less than 60 per minute or persistent hypotension reduce infusion rate by 0.2 μg/kg/h.Dexmedetomidine infusion will not be discontinued before extubation. Once the patient will be extubated, wean the infusion by 0.1μg/kg/h till reaching 0.2μg/kg/h. Slow the weaning rate if evidence of withdrawal reactions as agitation or hypertension occur. In clonidine group, the patients will receive 0.5μg/kg then 0.1-0.2 μg/kg/h.

Five ampoules of clonidine(750 μg) was drawn up and diluted in 45ml of normal saline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 60-70 yrs age ASA II, III Scheduled for CABG -

排除标准

  • History of mental illness Delirium or dementia patient refusal to participate Emergency procedures Any contraindications to study drugs

研究组 & 干预措施

dexmedetomidine group

Active Comparator

Upon arrival to ICU, in the dexmedetomidine group, patients will receive an infusion of 0.5-0.7 μg/kg/h then 1.4 μg/kg/h if Richmond assessment sedation score from +1 to +4

+4 Combative ,+3 Very agitated ,+2 Agitated,+1 Restless, 0 Alert and calm, -1 Drowsy , -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarrousable Taking into consideration if the heart rate less than 60 per minute or persistent hypotension reduce infusion rate by 0.2 μg/kg/h. Once the patient will be extubated, wean the infusion by 0.1μg/kg/h till reaching 0.2μg/kg/h. Slow the weaning rate if evidence of withdrawal reactions as agitation or hypertension occur.

干预措施: Dexmedetomidine (Drug)

clonidine group

Sham Comparator

In clonidine group, the patients will receive 0.5μg/kg then 0.1-0.2 μg/kg/h if Richmond assessment sedation score from +1 to +4 Five ampoules of clonidine(750 μg) will be drawn up and diluted in 45ml of normal saline.

干预措施: Clonidine (Drug)

结局指标

主要结局

the incidence of delirium

时间窗: every 4 hours in first day in ICU then every 8h for the next day, after discharge from ICU to the ward it will be checked every 8h for 5 days

disturbed level of consciousness that develops over a period of hours or days and fluctuates over time.

次要结局

  • length of ICU stay(2 days)

研究者

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

Hoda Shokri

Hoda Shokri

Ain Shams University

研究点 (1)

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