Is Rhabdomyolysis an Anesthetic Complication in Patients Undergoing Robot-assisted Radical Prostatectomy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Participants With serumCreatine Phosphokinase Values greater than 5000IU/L
研究概览
简要总结
In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum, intraoperative fluid restriction and prolonged Trendelenburg position may cause rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities.
In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative positioning, fluid restriction and length of surgery on development of RM in RARP patients during perioperative period.
详细描述
Fifty-two ASA I-II patients aged 50-80 years, BMI >25 kg/m2 scheduled for an elective RARP were enrolled to the study.
In all patients, pre-anesthetic evaluations including laboratory tests and Charlson Comorbidity Index (CCI) were performed one week before surgery in anesthesia clinic. Comorbid diseases were rated based on CCI. A 4-points scale was used to rate comorbid conditions [1 mild; 4 severe]. Comorbidity grading was performed by adding scores given for each comorbid disease. Based on the grading, patients were stratified into 4 groups as follows: grade 0, 1-2, 3-4 and ≥ 5
In the operation room, intubation was performed after standard anesthesia For surgery, patients were placed in low lithotomy position. All patients were placed on a soft sponge mattress and soft padding gel pads were provided above the shoulders. The patients were placed in a 30-degree STP after achieving pneumoperitoneum at an intra-abdominal pressure level of 15 mmHg. After placing patient to desired position (T0), blood samples were drawn for measurements of ABG, Na, Cl, Ca, K, BUN, Cr, AST, ALT, LDH, cTp-I, CK-MB and CPK.
During the operation, normal saline (1 m/kg/hr) and 6% HES 200/05 (1 ml/kg/hr) infusions were applied. Operation time (OT) and Trendelenburg time (TT) were recorded in all patients.
Blood samples were repeated on the hours 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery. Hydration with 2000 ml crystalloid solution was given until hour 24 after surgery. In all patients, urine output was monitored.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 50-80 years,
- •BMI >25 kg/m2
- •Patients scheduled for an elective RARP
排除标准
- •Patients with ASA III-IV risk status,
- •Patients with comorbid diseases that can cause increased muscular activity such as severe dystonia or status asthmaticus,
- •Patients with renal or hepatic failure and patients on statin or steroid therapy were excluded.
- •Patients converted to laparotomy during surgery.
结局指标
主要结局
Number of Participants With serumCreatine Phosphokinase Values greater than 5000IU/L
时间窗: Change from Baseline Creatine Phosphokinase at 24 hours.
Rhabdomyolysis was defined as postoperative serum Creatine Phosphokinase level exceeding 5000 IU/L.
次要结局
- number of patients with abnormal laboratory values(on the hours 0 (T9), 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery.)
研究者
Gulsah Karaoren
MD
Umraniye Education and Research Hospital