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

Xin Chen

Status and phase: Completed; Phase 4

Conditions: Total Laparoscopic Hysterectomy

Treatments: Drug: Tegileridine (tegileridine fumarate injection, IV); Drug: Oxycodone（Oxycodone Hydrochloride Injection，IV）

Study type: Interventional

Funder types: Other

Identifiers

NCT07326683

No.823RC592 (Other Identifier)

HUMU2H-TCOPOP-CN-2025

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Tegileridine（T group）

Experimental group

Description:

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).

Treatment:

Drug: Tegileridine (tegileridine fumarate injection, IV)

Oxycodone（O group）

Experimental group

Description:

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).

Treatment:

Drug: Oxycodone（Oxycodone Hydrochloride Injection，IV）