The Effect of Preemptive Administration of Pregabalin on Postoperative Pain and Respiratory Dynamics in Patients Undergoing Surgery for Robotic Radical Prostatectomy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- To investigate the impact of preemptive pregabalin on the postoperative pain
研究概览
简要总结
The study aimed to investigate the impact of preemptive pregabalin on the postoperative pain severity and the requirement of analgesic drugs in patients undergoing robotic radical prostatectomy surgery as primary outcome.
Additionally, it examined the effect of pregabalin on early postoperative respiratory dynamics as secondary outcome.
详细描述
Our study will be conducted on a total of 90 patients after ethics committee approval and patient consent. In the prospective observational study, patients will be divided into two groups: those who received preoperative pregabalin and those who did not.
Group 1: those who did not take pregabalin (n:45) Group 2: those who took pregabalin (n:45) Procedure to be applied (interventions) Those who have received pregabalin treatment drink 150 mg of pregabalin with a small amount of water 2 hours before the surgical procedure. All patients receive standard general anesthesia in the operating room after standard hemodynamic monitoring, invasive arterial pressure and Bispectral Index (BIS) monitoring.
Afterwards, all patients receive standard anesthesia maintenance and are monitored in mechanical ventilation (volume-controlled mode), PEEP at 7-8 cmH20 and ETCO2 level at 30-35mmHg during the pneumoperitoneum period. During the pneumoperitoneum period, intra-abdominal pressure is kept within the range of 12-14 mmHg.
During robotic surgery, the standard 45-degree upright Trendelenburg position and perioperative restrictive fluid management are performed. For postoperative analgesia, 0.06 mg/kg morphine, 1 gram (g) paracetomol and 8 mg onasetron are administered iv to all patients 30 minutes before the end of the operation. At the end of surgery and after extubation, patients are taken from the recovery unit to the service in accordance with Aldrete criteria. In the service, all patients are given paracetamol 1g every 8 hours and tenoxicam 20 mg every 24 hours for pain treatment. Tramadol 1 mg/kg iv is administered as rescue analgesic to patients with a VAS score >4.
Recording Data Patients' age, gender, BMI, and comorbidities are recorded. Perioperative heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2), BIS value, ETCO2, PaCO2 (arterial blood gas), PaO2/Fi02 and peak airway pressure (Ppeak), plateau pressure (Pplato). ) is recorded at the times specified below.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18-75 and with an ASA score of 1-3 who will undergo robotic radical prostatectomy (RARP) surgery under general anesthesia Exclusion criteria Under 18 years of age, over 75 years of age, ASA over 3, history of severe COPD and asthma, history of lobectomy/pneumonectomy, restrictive lung disease, congestive heart failure (NYHA stage 3-4), severe renal and hepatic dysfunction, history of neuromuscular disease, neurological and those with psychiatric problems, extreme obesity or malnutrition (Body mass index >30 or <20), chronic alcohol and opioid use, gabapentinoid, opioid allergy or intolerance, history of chronic pain or fibromyalgia, history of malignant neoplasm, history of gastrointestinal bleeding or perforation, patients in need of intensive care and those who do not consent
排除标准
- 未提供
结局指标
主要结局
To investigate the impact of preemptive pregabalin on the postoperative pain
时间窗: 5 times during surgery and up to 48 hours after surgery
to investigate the impact of preemptive pregabalin on the postoperative pain severity and the requirement of analgesic drugs in patients undergoing robotic radical prostatectomy surgery
次要结局
- the effect of pregabalin on early postoperative respiratory dynamics(5 times during surgery and up to 48 hours after surgery)
研究者
Senay Goksu
SPECIALIST, MD,
Umraniye Education and Research Hospital
