Effect of Equivalent Dose of Oxycodone or Tegileridine on Patients Undergoing Gynecological Laparoscopic Hysterectomy
| Registry | NCT07326683 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 68 (Actual) |
| Sponsor | Xin Chen (Other); collaborators: The Second Affiliated Hospital of Hainan Medical University |
| Conditions | Total Laparoscopic Hysterectomy |
| Interventions | Tegileridine (tegileridine fumarate injection, IV), Oxycodone（Oxycodone Hydrochloride Injection，IV） (Drug) |
| Dates | start 2025-12-17, primary completion 2026-01-13, completion 2026-01-13, first posted 2026-01-08, last updated 2026-04-17 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Total Laparoscopic Hysterectomy All trials of Tegileridine (tegileridine fumarate injection, IV) All trials of Oxycodone（Oxycodone Hydrochloride Injection，IV）
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tegileridine（T group） | Experimental | Drug: Tegileridine (tegileridine fumarate injection, IV) | 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). |
| Oxycodone（O group） | Experimental | Drug: Oxycodone（Oxycodone Hydrochloride Injection，IV） | 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). |
Sex: Female, ages: 18 Years to 65 Years
Inclusion Criteria: 1. Patients undergoing laparoscopic total abdominal hysterectomy with single-lumen endotracheal tube placement under general anaesthesia. 2. Females aged 18-65 years with a BMI of 18-28 kg/m²; 3. Normal mouth opening and head/neck mobility; 4. Preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III and Mallampati airway classification of I or II; 5. Patients must also be scheduled for postoperative analgesia and have signed an informed consent form. Exclusion Criteria: 1. Patients with allergies to the medications used in this study. 2. 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; 3. Patients with severe liver or kidney dysfunction, or concomitant severe endocrine disorders such as poorly controlled hypertension, diabetes, hyperthyroidism or hypothyroidism. 4. Patients with a difficult airway, oropharyngeal/cervical anomalies, or a history of prior tracheostomy; 5. A history of prolonged sedative/analgesic use, substance abuse or opioid dependence; 6. Patients with neuropsychiatric disorders or impaired communication/comprehension abilities.
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University | Haikou | China |