The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension in Rhinoplasty Procedures on Hemodynamics and Regional Renal Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Level of hypotension
研究概览
简要总结
In this study, the effects of nicardipine and esmolol applied for controlled hypotension in rhinoplasty on hemodynamics and regional renal oxygenation will be investigated.
详细描述
The procedure to be applied to the cases to be included in the study:
Patients randomized by the sealed envelope method will be divided into 2 groups (40 patients in each group).
The sealed envelopes that determine which group the patient will belong to will be randomly selected by the patient.
Standard general anesthesia will be applied to all patients. Before starting the surgical procedure; Group N (Nicardipine infusion) will be administered at a dose of 5-15mg/h, and Group E (Esmolol infusion) at a dose of 50-300mcg/kg/min.
- General anesthesia will be applied to all groups. Patients will be administered controlled hypotension (mean arterial pressure 50-60 mmHg).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18-60 years of age,
- •ASA I-II,
- •undergoing elective rhinoplasty surgery,
- •it was decided to apply controlled hypotension,
- •BMI (body mass index) between 18-25 kg/m2,
- •informed about the subject and
- •patients with written consent
排除标准
- •ASA III-IV patients,
- •hypertension disease,
- •using anticoagulant medication,
- •pregnancy,
- •kidney failure,
- •bleeding diathesis,
- •active infection,
- •allergy to drugs to be used,
- •refusing to participate in the study,
- •hypothermic,
- •patients taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors
结局指标
主要结局
Level of hypotension
时间窗: 1 year
Measuring mean blood pressures
Monitoring of renal oxygen saturation
时间窗: 1 year
Measurement of regional renal oxygenation
次要结局
未报告次要终点
研究者
Nureddin YUZKAT
Assoc. Professor
Yuzuncu Yıl University