Comparison of Ephedrine Versus Norepinephrine Efficacity to Correct Anesthesia Induction Related Hypotension in Chronic Renal Insufficiency Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of boluses
研究概览
简要总结
Hypotension occurs frequently after anesthesia induction and is more frequent in patients with chronic renal insufficiency. This hypotension occurs most frequently during the 20 minutes after anesthesia induction. Hypotension is commonly corrected by ephedrine bolus injection. However, presynaptic noradrenaline reserve may be lower in patients with chronic renal insufficiency rendering this treatment less effective. Another drug commonly used is norepinephrine, which action is independent of presynaptic noradrenaline storage.
The primary hypothesis is that in patients with chronic renal insufficiency, bolus injection of norepinephrine will be more effective then ephedrine injections to correct hypotension after anesthesia induction.
60 patients with a glomerular filtration rate less than 45 mL/min/m2 (KDIGO classification less than grade 3b) will be included in this prospective double blind trial. All patients will be anesthetized by target-controlled infusion of propofol adjusted to a patient state index (Measured by Sedline, Masimo) of 25-50. Sufentanil injection will be based on noxious stimuli according to the attending anesthesiologist's judgement.
Non-invasive blood pressure will be measured at the pre-anesthesia clinic, before induction and every minute up to 20 minutes post anesthesia induction. Episodes of hypotension, defined as a mean arterial blood pressure less than 65 mm Hg, will be treated either by a bolus injection of 6 mg ephedrine or a bolus injection of 6 mcg norepinephrine, which are equipotent doses. Seringues containing either ephedrine 3 mg/mL or norepinephrine 3 mcg/mL will be prepared by an anesthesia nurse not involved in the care of the patient and labeled as "VASO-IRC-inclusion number". Randomization will be done by a computer generated list in a block randomization of 5.
Primary outcome is the number of boluses needed to maintain arterial blood pressure above a mean of 65 mm Hg.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Drug will be prepared by an anesthesia nurse not involved in the care of the patient and labeled as "VASO-IRC-inclusion number".
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective non-cardiac surgery
- •general anesthesia
- •chronic renal insufficiency defined as a glomerular filtration rate < 45 mL/min/m2
排除标准
- •cardiac insufficiency with a left ventricular ejection fraction < 50%
- •severe cardiomyopathy
- •severe cardiac valvular disease
- •use of enzyme converting inhibitors or sartans less than 24h before surgery
- •use of alpha2 antihypertension medication
- •chronic treatment by: noradrenaline or dopamine recapture inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors
研究组 & 干预措施
Ephedrine group
In this group, any hypotension less than 65 mm Hg will be corrected by bolus injection of 6 mg ephedrine. Bolus injection will be repeated every 3 minutes, as needed, to keep mean arterial pressure above 65 mm Hg.
干预措施: Ephedrine (Drug)
Norepinephrine group
In this group, any hypotension less than 65 mm Hg will be corrected by bolus injection of 6 mcg norepinephrine. Bolus injection will be repeated every 3 minutes, as needed, to keep mean arterial pressure above 65 mm Hg.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Number of boluses
时间窗: 20 minutes after anesthesia induction
Primary outcome is the number of boluses of either ephedrine or norepinephrine needed to keep mean arterial blood pressure above 65 mm Hg
次要结局
未报告次要终点
研究者
Denis SCHMARTZ
Head, department of Anesthesiology
Brugmann University Hospital