Application of Remifentanil Target Controlled Infusion Combined With Ibuprofen Injection in Gynecologic Endoscopic Surgery of Female Motion Sickness Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Visual Analogue Score scores in postoperative resting state of patients in two groups
研究概览
简要总结
The goal of this clinical trial is to compare the analgesic effect of sufentanil and ibuprofen and the incidence of vomiting, and to choose better postoperative analgesic drugs for motion sickness patients.in describe participant population. The main questions it aims to answer are:
- Whether this anesthesia method can meet the analgesic needs of gynecological laparoscopic surgery.
- Whether this anesthesia method can reduce the incidence of nausea and vomiting in patients with motion sickness after gynecological laparoscopic surgery.
Participants will use target-controlled infusion anesthesia combined with 0.8g ibuprofen injection.
Researchers will compare with use of target-controlled infusion combined with sufentanil to see if the incidence of nausea and vomiting is higher.
详细描述
Abstract: Objective: To compare the analgesic effect of sufentanil and ibuprofen and the incidence of vomiting, and to choose better postoperative analgesic drugs for motion sickness patients. Methods: Sixty-eight female patients aged between 18 and 60 years with motion sickness were selected for gynecologic endoscopic surgery under general anesthesia. Sixty-eight female patients were randomly divided into two groups, Group B (ibuprofen group) and Group S (sufentanil group), using a random number table method. The initial plasma target concentration of propofol was set at 4ug/ml and adjusted using the titration method. Once the patient lost consciousness, the target concentration of remifentanil was set at 4ng/ml and rocuronium at 0.6mg/kg, followed by endotracheal intubation three minutes later. During the operation, the plasma target concentration of propofol was maintained at 5ug/ml and remifentanil at 4ng/ml, with adjustments made based on stress reaction levels. General anesthesia was sustained through continuous administration of rocuronium at doses of 5 µg/kg/min. In Group B (ibuprofen group), intravenous administration of ibuprofen (0.8g) took place within half an hour before the end of surgery; in Group S (sufentanil group), intravenous injection of sufentanil (0.2ug/kg) occurred half an hour before completion of the operation, along with intravenous injection of dexamethasone (5mg) five minutes prior to anesthesia induction to prevent postoperative nausea and vomiting in both groups. The following data were collected: duration of operation, pneumoperitoneum time, extubation time, respiratory recovery time; Incidence of postoperative nausea and vomiting at different time intervals: Postanesthesia care unit residence period (T1), 0-3h after extubation (T2), 3-6h after extubation (T3), 6-12h after extubation (T4), 12-24h after extubation (T5); Visual analogue pain score : Postanesthesia care unit residence period (T1), 0-3h after extubation (T2), 3-6h after extubation (T3), 6-12h after extubation (T4), 12-24h after extubation (T5); Frequency of use of analgesics and antiemetic drugs; Incidence of adverse reactions within 24 hours after surgery; Postoperative satisfaction.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years old;
- •Class I - II patients according to the American Society of Anesthesiologists classification;
- •Body mass index : 20-27kg/㎡;
- •non-life-threatening diseases of heart, lung, brain, liver, kidney and other important organs;
- •No recent use of sedatives, opioids, non-steroidal drugs such as ibuprofen, antiemetic drugs.
- •No history of digestive tract ulcer;
- •Motion sickness patients undergoing gynecological endoscopic surgery under general anesthesia.
- •Postoperative analgesia pump is not required.
排除标准
- •Low weight, poor general state;
- •general anesthesia drug allergy;
- •Long-term use of painkillers, antiemetic drugs, or use of opioids within 12 hours before surgery.
研究组 & 干预措施
Ibuprofen Group
Participants received 0.8g ibuprofen intravenously 30 minutes before the end of the procedure
干预措施: Ibuprofen (Drug)
Sufentanil Group
Participants received 0.2ug/kg of sufentanil intravenously 30 minutes before the end of the procedure
干预措施: sufentanil (Drug)
结局指标
主要结局
Visual Analogue Score scores in postoperative resting state of patients in two groups
时间窗: From the end of surgery until 24 hours after surgery
Visual analogue pain score : Pstanesthesia care unit residence period (T1), 0-3h after extubation (T2), 3-6h after extubation (T3), 6-12h after extubation (T4), 12-24h after extubation (T5)； Pain score 24h after operation: Pain Assessment Scale was used to evaluate the analgesic effect of the two groups. 0 doesn't hurt; 1 to 3 points - mild pain; 4 to 6 points - moderate pain; Score 7-10 - severe pain
Comparison of vomiting between the two groups
时间窗: From the end of surgery until 24 hours after surgery
Postoperative vomiting score 24 hours after surgery: Postoperative vomiting was divided into 0-3 points according to the degree of vomiting. 0 score: no vomiting; 1 point: vomiting 1-2 times; 2 points: vomiting 3 to 5 times; 3 marks: vomiting \> 5 times
Comparison of postoperative nausea and vomiting between the two groups
时间窗: From the end of surgery until 24 hours after surgery
Incidence of postoperative nausea and vomiting at different time intervals: Pstanesthesia care unit residence period (T1), 0-3h after extubation (T2), 3-6h after extubation (T3), 6-12h after extubation (T4), 12-24h after extubation (T5); postoperative nausea and vomiting grading 24h after surgery: According to the severity of postoperative nausea and vomiting， postoperative nausea and vomiting was divided into 1-4 grades. Grade I: no nausea or vomiting; Grade II: mild nausea, abdominal discomfort, but no vomiting; Grade III: obvious vomiting, but no contents of the vomit; Grade IV: Severe vomiting with gastric juices and other contents. Postoperatively PONV is considered to occur in patients with grade II or higher
次要结局
- Time of pneumoperitoneum(From the beginning to the end of the surgery)
- Occurrence of adverse reactions(Within 24 hours of extubation)
- Extubation time(One minute after surgery)
- Respiratory recovery time(One minute after surgery)
- Score of patient satisfaction(From the end of surgery until 24 hours after surgery)
- Time of operation(From the beginning to the end of the surgery)
- Volume of fluids and blood loss(From the beginning to the end of the surgery)