Can we Get Conscious Sedation in Optimal Safety Conditions in an Emergency Department, by Combining Dexmedetomidine With Alfentanil?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Ramsay score scale
研究概览
简要总结
The main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department.
Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.
Patients will also receive a dose of alfentanil, 1 minute before the technical act.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:
- •The insertion of a chest drain
- •Abscess incision and drainage
- •Closed reduction of a dislocated joint
排除标准
- •Patients refusing to participate in the study (refusal to sign the consent form)
- •Patients refusing sedation
- •Patients unable to participate in the study (consent is impossible to obtain)
- •Pregnant women
- •The hypersensitivity to the active ingredient, dexmedetomidine hydrochloride.
- •Patients with poor respiratory status determined by:
- •Respiratory rate > 30 / min Oxygen saturation <90%
- •Patients with unfavorable hemodynamic status determined by :
- •A heart rate > 120 / min A heart rate < 50 / min Systolic blood pressure ≥ 180 mmHg or ≤100mmHg Diastolic blood pressure ≥ 110mmHg
- •Patients with contraindication to the use of dexmedetomidine :
- •Advanced heart block (level 2 or 3) unless pacemaker Acute cerebrovascular disease
研究组 & 干预措施
Dexmedetomidine and Alfentanil
Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.
At time zero, the patient will receive a bolus 1 mcg/ kg of dexmedetomidine during 10 minutes.
Patients over 65 years will receive a bolus of 0.5 mcg/kg of dexmedetomidine during 10 minutes.
Afterwards, the patient will receive a continuous injection of 0.6 mcg/kg/h of dexmedetomidine
Patients will also receive a dose of alfentanil 1 mcg /kg, 1 minute before the technical act.
A new alfentanil dose of 0.5 mcg / kg may be injected if pain reported by the patient corresponds to an EN > 50.
The maximum dose of alfentanil the patient can receive is 5 mcg / kg.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine and Alfentanil
Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.
At time zero, the patient will receive a bolus 1 mcg/ kg of dexmedetomidine during 10 minutes.
Patients over 65 years will receive a bolus of 0.5 mcg/kg of dexmedetomidine during 10 minutes.
Afterwards, the patient will receive a continuous injection of 0.6 mcg/kg/h of dexmedetomidine
Patients will also receive a dose of alfentanil 1 mcg /kg, 1 minute before the technical act.
A new alfentanil dose of 0.5 mcg / kg may be injected if pain reported by the patient corresponds to an EN > 50.
The maximum dose of alfentanil the patient can receive is 5 mcg / kg.
干预措施: Alfentanil (Drug)
结局指标
主要结局
Ramsay score scale
时间窗: 2 hours
次要结局
- Number of participants with adverse events(2 hours)