The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- the incidence and severity of PONV(Postoperative nausea and vomiting)
研究概览
简要总结
To maximize the surgical visual field, Robot-assisted laparoscopic radical prostatectomy (RLRP) usually requires the patient to be positioned in a steep trendelenburg position in combination with prolonged intraperitoneal carbon dioxide (CO2) insufflation and increased intrabdominal pressure. Insufflations of CO2 during laparoscopic surgery, which causes stretch and irritation of the peritoneum, is known to play an important role in postoperative nausea and vomiting (PONV). In addition, prolonged pneumoperitoneum increases the risk for PONV. PONV can cause patient discomfort and prolong post anaesthesia care unit (PACU) stay. In addition, the patient with PONV is also predisposed to severe complications such as aspiration pneumonia, increased wound dehiscence, delayed recovery, prolonged hospital stay, and eventually increased medical cost.
详细描述
To maximize the surgical visual field, Robot-assisted laparoscopic radical prostatectomy (RLRP) usually requires the patient to be positioned in a steep trendelenburg position in combination with prolonged intraperitoneal carbon dioxide (CO2) insufflation and increased intrabdominal pressure. Insufflations of CO2 during laparoscopic surgery, which causes stretch and irritation of the peritoneum, is known to play an important role in postoperative nausea and vomiting (PONV). In addition, prolonged pneumoperitoneum increases the risk for PONV. PONV can cause patient discomfort and prolong post anaesthesia care unit (PACU) stay. In addition, the patient with PONV is also predisposed to severe complications such as aspiration pneumonia, increased wound dehiscence, delayed recovery, prolonged hospital stay, and eventually increased medical cost. Therefore, as RLRP itself can be an important risk factor of PONV, the anaesthesiologist should give attention to prevent PONV in this patient group, although they usually have lower risk in terms of patient-related factors. Previously published studies have recommended antiemetic prophylaxis for the patients with moderate-to-high risk of PONV. However, despite routine use of prophylactic antiemetics, laparoscopic surgery has been associated with higher incidence of PONV.Previous clinical studies suggested that total intravenous anaesthesia (TIVA) with propofol reduced PONV significantly compared to inhaled anaesthetics. Also, several studies have recommended TIVA with propofol as the anaesthetic method in patients with high risk of PONV. However none of these studies were designed and powered to detect differences in PONV in patients undergoing laparoscopic surgery, especially RLRP.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing RLRP, ASA physical status I or II, age 50 to 70.
排除标准
- •Emergency operation.
- •patients with motion sickness or PONV history to control anticipated risk of PONV.
- •Patients with antiemetic use within 24 hours before surgery.
- •Patients with regular corticosteroid use.
- •Patients with chemotherapy within 4 or radiotherapy within 8 weeks.
- •Patients with allergy to any of the study drugs.
- •Patients with liver dysfunction, confirmed renal impairment, or obesity (body mass index > 35 kg/m2).
研究组 & 干预措施
Control group
balanced anaesthesia with antiemetic prophylaxis
干预措施: Propofol anesthesia (Drug)
TIVA group
TIVA without antiemetic prophylaxis
干预措施: Propofol anesthesia (Drug)
TIVA-P group
TIVA with antiemetic prophylaxis
干预措施: Propofol anesthesia (Drug)
结局指标
主要结局
the incidence and severity of PONV(Postoperative nausea and vomiting)
时间窗: 48 hours after the surgery
Comparison of the incidence and severity of PONV 48 hours after the surgery.
次要结局
未报告次要终点
