The Effects of Low Flow and Normal Flow Desflurane Anesthesia on Postoperative Liver and Renal Functions and Serum Cystatin C Levels in Geriatric Patients: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Alanin Aminotransferaz (ALT)
研究概览
简要总结
Aging is a physiological process. In the elderly, loss of functional reserve in all organ system, regression in anabolic processes and increase in catabolic processes are observed s (1). The number of geriatric patients is also increasing in our country. Technological developments in anesthesia and surgery technics show that we will provide medical services to more elderly patients over time(2). Cystatin C is excreted only by the kidney (7, 8). Serum cystatin C level is not affected by body muscle mass, age and gender. The half-life is short. Because of all these features, it is thought to be more sensitive than creatinine in evaluating kidney functions (8,9). In this study, it was aimed to compare the effects of low flow and normal flow desflurane anesthesia applied in geriatric patients on postoperative liver and kidney functions and serum cystatin C levels.
详细描述
This prospective, randomized-controlled, observational study was approved by the ethics committee of Van Yuzuncu Yıl University (Date: 16.04.2021, Decision no: 05-27). The study was performed according to the World Medical Association's Declaration of Helsinki. All enrolled patients provided written informed consent.
In this prospective study; the patients were randomly divided into 2 groups according to the fresh gas flow applied. 'Group D' (n=30) was given to the low flow anesthesia group; the group in which normal flow anesthesia was administered was named 'Group N' (n=30).
Before anesthesia, automatic calibration of the anesthesia device (Primus, Drager) and leak tests were performed. In addition, the leak test was repeated manually for each patient. Alarm limits of the anesthesia device; The lower limit of inspired oxygen concentration (FiO2) was set to 30%, upper limit of inspired CO2 to 3%, and upper limit of end-tidal carbon dioxide (etCO2) to 45 mmHg.
The disconnection alarm was set to be 5 cmH2O lower than the peak pressure, the occlusion alarm was set to 30 cmH2O, the lower expiratory gas volume lower limit was set to be 500 mL below the desired minute volume (MV).
Soda lime (Sorbo-lime, Berkim, Turkey) was used as carbon dioxide absorbent. Soda lime was checked frequently for color and changed at appropriate times. Disposable anesthesia circuit and bacterial filter were used for each case.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an American Society of Anesthesiologists (ASA) status of class I-III,
- •Aged between 65 and 100 years,
- •Scheduled to undergo general anesthesia and, the surgeries that will take longer than 1 hour.
排除标准
- •ASA class ≥ III patients
- •Thorasic surgery
- •Neurosurgery
- •Cardiorespiratory disease,
- •Uncontrolled diabetes mellitus,
- •Coagulation disorders,
- •Preoperative liver and renal dysfunction,
- •History of malignant hyperthermia,
- •Using nephrotoxic or hepatotoxic drugs,
- •Major bleeding (>1000 cc) is predicted in the operation,
- •Chronic alcoholism,
- •Patients with drug use or withdrawal symptoms
研究组 & 干预措施
Low flow desflurane anesthesia (Group D)
All patients were preoxygenated for three minutes. Midazolam 0.03 mg/kg, fentanyl 1.5 mcg/kg , propofol 2 mg/kg and rocuronium 0.6 mg/kg were administered iv for induction of anesthesia. After intubation all patients were mechanically ventilated with 50% O2+50% air + 6-7% desflurane in a 4 L/min fresh gas flow until the MAC value reached 1. When the MAC value of desflurane was 1, fresh gas flow was decreased to 0.5 L/min (60% O2+40% air) in Group D. Hemodynamic parameters, SpO2 and BIS values were recorded after induction, at the beginning of low flow/normal flow anesthesia and every 5 minutes during surgery. The patients were observed in terms of side effects and complications during the operation and in the postoperative period. To research the liver and the kidney functions, blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
干预措施: Low flow desflurane anesthesia (Group D) (Drug)
结局指标
主要结局
Alanin Aminotransferaz (ALT)
时间窗: 24 hours
To research the serum alanin Aminotransferaz (ALT) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
Aspartat Aminotransferaz (AST)
时间窗: 24 hours
To research the serum Aspartat Aminotransferaz (AST) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
Serum creatinine
时间窗: 24 hours
To research the serum creatinine , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
Serum cystatin C
时间窗: 24 hours
To research the Serum cystatin C , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
Blood urea nitrogen (BUN)
时间窗: 24 hours
To research the Blood urea nitrogen (BUN) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
次要结局
- Heart rate (HR)(6 hours)
- Systolic blood pressure (SBP)(6 hours)
- Diastolic blood pressure (DBP)(6 hours)
- Mean blood pressure (MBP)(6 hours)
- Drug allergies(24 hours)
- Nausea-vomiting(24 hours)
- İnsufficient depth of anesthesia(During surgery)
- Shivering and agitation(24 hours)
研究者
Hacı Yusuf Güneş
Assistant proffesor
Yuzuncu Yıl University