Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- 15-item recovery quality scale score 48 hours after surgery
研究概览
简要总结
The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective laparoscopic sleeve gastrectomy
- •ASAA I or grade;
- •volunteered in this trial and signed informed consent; ④ age 18-65 years; ⑤ BMI> 30kg / m2.
排除标准
- •chronic pain;
- •severe liver dysfunction (total bilirubin 2 mg dl-1);
- •severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2);
- •pregnancy or lactation;
- •preoperative heart rate <50 beats / min, sick sinus syndrome, severe heart block; -dementia or significant neurological disorders (such as stroke, epilepsy, intracranial tumors, PD, etc.);
- •history of alcohol or drug abuse
研究组 & 干预措施
Opioid-free group
干预措施: Opioid-free Analgesics (esketamine, dexmedetomidine) (Drug)
Opioid group
干预措施: Opioid Anesthetics (sufentanil and remifentanil) (Drug)
结局指标
主要结局
15-item recovery quality scale score 48 hours after surgery
时间窗: 48 hours after surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
15-item recovery quality scale score 24 hours before surgery
时间窗: 24 hours before surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
15-item recovery quality scale score 24 hours after surgery
时间窗: 24 hours after surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
次要结局
- Dosage of postoperative analgesics(48 hours after surgery)
- time of first postoperative mobilization(24 hours after surgery)
- time to first exhaust gas after surgery(24 hours after surgery)
- Acute pain numeric rating scale score(6, 24, 48 hours after surgery)
- Duration of until postoperative PACU Aldrete score> 9 points(up to 30 min after surgery at postoperative recovery room)
- anesthesia-related complication(24 hours after surgery)
- Overall benefit of analgesic score satisfaction in pain treatment(6, 24, 48 hours after surgery)
- Rhodes Index of Nausea, Vomiting, and Retching(6, 24, 48 hours after surgery)
研究者
Bijia Song
principal investigator
Beijing Friendship Hospital