Evaluation of the Effects of Two Different Sedation Protocols Used in Patients Undergoing Spinal Anesthesia on Cardiac Electrophysiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- ICEBc
研究概览
简要总结
The QT interval is a measure of the combination of cardiac depolarization and repolarization as it encompasses both the QRS complex and the J-T interval. QT, QTc, QTd prolongation or shortening has been associated with ventricular arrhythmias . In order to define non-torsogenic drug-induced arrhythmias, the index of cardio-electrophysiological balance (iCEB), which is a new marker calculated with the QT/QRS formula, has been defined. In our study, we planned to evaluate the effects of dexmedetomidine and propofol on cardiac electrophysiology with all these parameters, especially the newly defined iCEB.
详细描述
Seventy patients who underwent operation under regional anesthesia and received intraoperative sedation will be included in the study. The patients will be divided into two groups, Group D (dexmedetomidine) and Group P (propofol). Sedative agent infusion will be started immediately after spinal anesthesia is administered. Preoperative ASA (American Society of Anesthesiologists) scores, demographic data, comorbidities and medications used will be recorded. Vitals and ECG prior to spinal anesthesia will be recorded. After that, spinal anesthesia will be applied and vitals and ECG will be recorded at 1, 5, 10, 15, 45 and 75 minutes. The sedation levels of the patients will be measured noninvasively by bispectral index (BIS) monitoring. Patients will be kept within the limits of light sedation. The maximum dose of 1.4 micrograms/kg/hour in the dexmedetomidine group (group D, n=35) and 4.5 milligrams/kg/hour in the propofol group (group P, n=35) will not be exceeded. The following parameters were set as the safety endpoint during sedation:
- Respiratory rate ≤8
- SpO2; 95
- Heart rate; 40
- Systolic blood pressure;80 At these endpoints, the patient's sedation dose will be reduced regardless of the BIS value.
During sedation, patients will be given 3 liters of nasal oxygen per minute, which can be increased according to need. Just before and 1st, 5th, 10th, 15th, 45th, 75th minutes after spinal anesthesia systolic arterial pressure, diastolic arterial pressure, mean arterial pressure,peak heart rate, oxygen saturation, bispectral index, QT time, QTc, QT distribution, Tpe, iCEB will be evaluated.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ASA Ⅰ-Ⅱ ,
- •18-80 years old, who will be operated under spinal anesthesia
排除标准
- •Hypersensitivity to the propofol,dexmedotimidine
- •preoperative QTc prolongation
- •preoperative heart disease
- •use of drugs that affect the QT interval
- •severe sinus bradycardia
- •preoperative electrolyte abnormalities
- •liver and kidney function abnormalities
- •non-sinus rhythm
结局指标
主要结局
ICEBc
时间窗: İntraoperative 10th minute
QTc/QRS formula
次要结局
- ICEB(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
- non invaziv diastolic blood pressure(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
- QTc(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
- Tpe(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
- non invaziv systolic blood pressure(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
- ICEBc(Baseline,İntraoperative 1th,5th,15th,30th,45th,75th minute)
- QT(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
- Bispektral index(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
- QTd(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
- Heart Rate(Baseline,İntraoperative 1th,5th,10th,15th,30th,45th,75th minute)
研究者
Burak NALBANT
assistant professor
Ankara City Hospital Bilkent