跳至主要内容
临床试验/NCT01402622
NCT01402622已完成4 期

The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

balanced anaesthesia with antiemetic prophylaxis

干预措施: Propofol anesthesia (Drug)

TIVA group

Active Comparator

TIVA without antiemetic prophylaxis

干预措施: Propofol anesthesia (Drug)

TIVA-P group

Active Comparator

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

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验