QT Changes in Geriatric Patients: a Comparison of Spinal and General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- QTc interval
研究概览
简要总结
QT interval, defined as the time between the beginning of the QRS complex and the end of the T wave in electrocardiography (ECG), is an indicator of depolarization and repolarization of the myocardium.11 Prolongation of the heart rate corrected QT (QTc) interval reflects electrical instability of ventricles and is associated with life-threatening ventricular arrhythmias, including torsade de pointes, ventricular fibrillation and sudden cardiac death.
Spinal anesthesia can cause profound prolongation of the QTc interval due to disparity between lumbar and thoracic sympathetic activity following subarachnoid block. Meanwhile inhalational anesthetics, sevoflurane, isoflurane, and desflurane are known to prolong QTc interval and intravenous anesthetics such as propofol, thiopental, etomidate and ketamin can also cause remarkable prolongation of the QTc interval. Moreover laryngoscopy and intubation may contribute to prolongation of the QTc interval because of the sympathetic stimulation.
Over the years it has been occurred an increase in the proportion of elderly population requiring surgical anesthesia. The incidence of ventricular arrhythmias increases in advancing age even in the absence of underlying heart disease and elderly patients have reduced physiological functions and poor tolerance to anesthesia. However the choice of anesthesia type is critical in this population.
To the best of knowledge, there was no published study to compare spinal anesthesia and inhalational anesthesia in elderly patients with regard to the QT interval changes. Investigators aimed to investigate the effects of spinal anesthesia on QT, QTc intervals and to compare general anesthesia with sevofluran in elderly patients.
详细描述
Investigators designed a prospective, randomized trial to compare spinal and general anesthesia in elderly patients on the effects of QT interval changes. The study protocol was approved by the Health Science University Haseki Training and Research Hospital Ethics Committee, Istanbul, Turkey (date: 03/29/2023 and number: 44-2023). This study was conducted according to the Declaration of Helsinki, and written informed consent was obtained from all patients. The study was performed at a tertiary referral hospital with 700 beds in Istanbul, Turkey between 03/29/2023-05/29/2023.
The patients who will undergo lower abdominal or extremity surgery and urological surgery older than 65 years will be included in this study. The exclusion criteria are as follows: any preoperative ECG abnormalities, QTc interval > 440 ms, family history of long QT syndome, use of any medications known to affect the QTc interval, serum electrolyte abnormalities, any contraindications for spinal anesthesia (e.g. coagulation disorders), unstable angina pektoris, chronic obstructive pulmonary disease, hepatic or renal failure, American Society of Anesthesiologists (ASA) physical classification status > III, pregnancy and obesity (BMI > 30).
Participants will be divided into two groups: the spinal anesthesia (group S) and general anesthesia (group G). Randomization and group allocations will be performed by a researcher who did not participate the collection of data.
In the preoperative care unit all patients will receive 10 ml/kg Ringer's lactate solution via a peripheral vein over 30 minutes. In the operating room premedication will be obtained with 0.015 mg/kg of midazolam and 1 µg/kg fentanyl intravenously.
In group G, a 2.0 mg/kg propofol injection will be used for the induction of anesthesia and facilitating of endotracheal intubation was provided with 0.6 mg/kg rocuronium. After the intubation the patients will be ventilated with a 6-8 ml/kg of tidal volume in volume control ventilation (VCV) mode with an anesthesia machine (Dräger Primus, Dräger Medical Systems, Inc. Danvers, MA, USA). Frequency of respiration will be adjusted to maintain PET CO2 at 32-36 mm Hg. Maintenance of anesthesia will be provided with sevoflurane (1.5-2%) in an oxygen-air mixture (FiO2 = 0.4) and 0.015 mg/kg rocuronium as needed. At the end of the surgery residual neuromuscular block will be antagonized with 4 mg/kg sugammedex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who scheduled lower abdominal or extremity surgery and urological surgery older than 65 years were enrolled to the study.
排除标准
- •any preoperative ECG abnormalities, QTc interval > 440 ms, family history of long QT syndome, use of any medications known to affect the QTc interval, serum electrolyte abnormalities, any contraindications for spinal anesthesia (e.g. coagulation disorders), unstable angina pektoris, chronic obstructive pulmonary disease, hepatic or renal failure, American Society of Anesthesiologists (ASA) physical classification status > III, pregnancy and obesity (BMI > 30).
结局指标
主要结局
QTc interval
时间窗: before anesthesia induction or spinal anesthesia; 1, 5 and 10 minutes after endotrakeal intubation or spinal anesthesia; after extubation or surgery
QTc interval on ECG calculated with Bazzets formula
次要结局
- QT(before anesthesia induction or spinal anesthesia; 1, 5 and 10 minutes after endotrakeal intubation or spinal anesthesia; after extubation or surgery)
研究者
Sinan Uzman
associate prof
Haseki Training and Research Hospital