Effect of Equivalent Dose of Oxycodone or Tegileridine on Patients Undergoing Gynecological Laparoscopic Hysterectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The occurrence of postoperative nausea and vomiting
研究概览
简要总结
This randomized, double-blind, controlled study aims to evaluate the efficacy and safety of Tegileridine or Oxycodone for postoperative analgesia in patients undergoing Total Laparoscopic Hysterectomy（TLH）. Subjects will be randomly assigned to receive an equivalent dose of intravenous Tegileridine or Oxycodone as part of a standard postoperative analgesia regimen. All patients will have access to rescue opioid analgesia according to the protocol. The primary outcome measures are the incidence of postoperative nausea and vomiting in two groups receiving a single dose of equivalent morphine analgesics (Group Tegileridine or Group Oxycodone).The secondary endpoints were designed to compare the success rate of postoperative analgesia, cumulative opioid consumption within 48 hours postoperatively, the time to first rescue analgesia, and the incidence of adverse events such as sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study via predefined stop-and-report procedures. The study results will evaluate whether teglitazide provides a more effective, better-tolerated analgesic regimen for patients undergoing total laparoscopic hysterectomy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic total abdominal hysterectomy with single-lumen endotracheal tube placement under general anaesthesia.
- •Females aged 18-65 years with a BMI of 18-28 kg/m²;
- •Normal mouth opening and head/neck mobility;
- •Preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III and Mallampati airway classification of I or II;
- •Patients must also be scheduled for postoperative analgesia and have signed an informed consent form.
排除标准
- •Patients with allergies to the medications used in this study.
- •Patients with severe diseases of major organs, such as the heart, lungs or brain, including a history of acute myocardial infarction, cerebral infarction, asthma or chronic obstructive pulmonary disease;
- •Patients with severe liver or kidney dysfunction, or concomitant severe endocrine disorders such as poorly controlled hypertension, diabetes, hyperthyroidism or hypothyroidism.
- •Patients with a difficult airway, oropharyngeal/cervical anomalies, or a history of prior tracheostomy;
- •A history of prolonged sedative/analgesic use, substance abuse or opioid dependence;
- •Patients with neuropsychiatric disorders or impaired communication/comprehension abilities.
研究组 & 干预措施
Tegileridine（T group）
Around 20 minutes before the end of the operation, patients in the T group were given 0.01 mg/kg of Tegileridine(dissolved in 10 ml of 0.9% sodium chloride injection solution. This was administered via continuous infusion at a rate of 60 ml/h).
干预措施: Tegileridine (tegileridine fumarate injection, IV) (Drug)
Oxycodone（O group）
Around 20 minutes before the end of the operation, patients in the O group were given 0.06 mg/kg of Oxycodone(dissolved in 10 ml of 0.9% sodium chloride injection solution. This was administered via continuous infusion at a rate of 60 ml/h).
干预措施: Oxycodone（Oxycodone Hydrochloride Injection，IV） (Drug)
结局指标
主要结局
The occurrence of postoperative nausea and vomiting
时间窗: Within 48 hours after surgery
Following surgery, a blinded evaluator assessed PONV using a 4-point ordinal scale (0 = none, 1 = nausea, 2 = retching, 3 = vomiting). Nausea was defined as a subjectively unpleasant sensation associated with awareness of the urge to vomit. Retching was defined as labored, spasmodic, rhythmic contraction of the respiratory muscles without expulsion of gastric contents. Vomiting was defined as the forceful expulsion of gastric contents from the mouth.
Success rate of postoperative pain management
时间窗: After the surgery, before leaving the recovery room（Day 0）
Following extubation during anaesthesia recovery after surgery, pain intensity was assessed at rest using a 10-cm visual analogue scale (VAS) by a blinded evaluator (with a minimum score of 0 indicating no pain and a maximum score of 10 indicating the most severe pain imaginable). Analgesia was recorded as successful when the VAS score was ≤3; otherwise, it was considered unsuccessful.
次要结局
- Success rate of postoperative pain management(After the surgery, before leaving the recovery room（Day 0）)
- Richmond Agitation and Sedation Scale(RASS)(Immediately before removal of the endotracheal tube (Postoperative Day 0).)
- Time of First Pressing of the PCIA(Within 48 hours after surgery)
- Overall incidence of adverse reactions(Within 48 hours after surgery)
研究者
Xin Chen
Associate Researcher,the Second Affiliated Hospital of Hainan Medical University
Hainan Medical College