Effect of Opioid-free General Anesthesia on Postoperative Nausea and Vomiting in Laparoscopic Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Total incidence of post-operative nausea
研究概览
简要总结
Post-operative nausea and vomiting (PONV) is common for the patients undergoing laparoscopic gynecologic surgery. PONV is a major factor for patient dissatisfaction, delayed patient recovery and increased medical expenses. Opioid-reducing anesthetic regimen is known to decrease PONV and facilitate early recovery after surgery (ERAS) and has been widely accepted recently. In this study, the researchers intend to investigate whether opioid-free anesthesia effectively reduces PONV, and whether it is clinically safe and feasible.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laparoscopic gynecologic surgery (≥90 min) for benign or malignant uterine/ovarian disease
- •ASA (American Society of Anesthesiologists) class I-II
排除标准
- •Uncontrolled hypertension
- •Untreated intracranial aneurysm
- •Severely impaired renal or hepatic function
- •Pregnancy
- •History of hypersensitivity for drugs used in the study
- •Patients not using NSAID-containing IV PCA (patient controlled analgesia) device post-operatively
研究组 & 干预措施
Group OFA (Opioid-free anesthesia)
Not using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation)
干预措施: Opioid-free anesthesia (Procedure)
Group OUA (Opioid-using anesthesia)
Using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil)
干预措施: Opioid-using anesthesia (Procedure)
结局指标
主要结局
Total incidence of post-operative nausea
时间窗: up to post-operative day 2
Y/N
次要结局
- Severity of post-operative nausea(day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2)
- Incidence of post-operative nausea(day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2)
- Rescue antiemetic agent use(day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2)
- Post-operative pain score(day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2)
- Incidence of post-operative retching/vomiting(day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2)
- Rescue pain medication use(day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2)
研究者
Hyo-Seok Na
Associate professor
Seoul National University Bundang Hospital