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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-20

Study Completion Date

2026-02-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Tegileridine (tegileridine fumarate injection, IV)

Intervention Type DRUG

Tegileridine (tegileridine fumarate injection, IV) is a small-molecule μ-opioid receptor agonist with G-protein-biased signaling (relative to β-arrestin-2 recruitment), developed by Jiangsu Hengrui for postoperative analgesia. It is administered intravenously and was first approved in China in January 2024 for the treatment of moderate-to-severe pain after abdominal surgery; in this study, tegileridine is used as part of standardized multimodal analgesia according to protocol. In China it is regulated as a narcotic 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).

Group Type EXPERIMENTAL

Oxycodone（Oxycodone Hydrochloride Injection，IV）

Intervention Type DRUG

Oxycodone bitartrate is a dual opioid receptor agonist that is used in clinical settings. Oxycodone bitartrate injection is indicated for the relief of moderate to severe cancer pain. It can be administered alone or in combination with non-steroidal anti-inflammatory drugs to provide acute combined analgesia. In January 2021, Jiangsu Enhua Pharmaceutical submitted a marketing authorisation application for Oxycodone bitartrate injection to the National Medical Products Administration.The application has been accepted and approved.

Interventions

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Tegileridine (tegileridine fumarate injection, IV)

Tegileridine (tegileridine fumarate injection, IV) is a small-molecule μ-opioid receptor agonist with G-protein-biased signaling (relative to β-arrestin-2 recruitment), developed by Jiangsu Hengrui for postoperative analgesia. It is administered intravenously and was first approved in China in January 2024 for the treatment of moderate-to-severe pain after abdominal surgery; in this study, tegileridine is used as part of standardized multimodal analgesia according to protocol. In China it is regulated as a narcotic drug.

Intervention Type DRUG

Oxycodone（Oxycodone Hydrochloride Injection，IV）

Oxycodone bitartrate is a dual opioid receptor agonist that is used in clinical settings. Oxycodone bitartrate injection is indicated for the relief of moderate to severe cancer pain. It can be administered alone or in combination with non-steroidal anti-inflammatory drugs to provide acute combined analgesia. In January 2021, Jiangsu Enhua Pharmaceutical submitted a marketing authorisation application for Oxycodone bitartrate injection to the National Medical Products Administration.The application has been accepted and approved.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No