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Clinical Study of Equivalent Doses of Oxycodone or Tegileridine on Patients Undergoing Gynecological Laparoscopic Hysterectomy

Clinical Study of Equivalent Doses of Oxycodone or Tegileridine on Patients Undergoing Gynecological Laparoscopic Hysterectomy

Recruiting
18-65 years
Female
Phase 4

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Overview

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 objective is to determine if a single application of an equivalent dose of Tegileridine or Oxycodone can keep VAS scores at or below 3 during the anesthesia recovery phase. The secondary objectives are to compare cumulative opioid consumption within 48 hours postoperatively, time to first rescue analgesia, and the incidence rate of adverse events, such as nausea, vomiting, 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.

Eligibility

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.

Study details
    Total Laparoscopic Hysterectomy

NCT07326683

Xin Chen

1 February 2026

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