Clinical Study of Equivalent Doses of Oxycodone or Tegileridine on Patients Undergoing Gynecologi… (NCT07326683) | Clinical Trial Compass
CompletedPhase 4
Clinical Study of Equivalent Doses of Oxycodone or Tegileridine on Patients Undergoing Gynecological Laparoscopic Hysterectomy
China68 participantsStarted 2025-12-17
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
The occurrence of postoperative nausea and vomiting