Completed

Efficacy and Safety of Tegileridine and Oliceridine Injections for Postoperative Pain

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Study Aim

This study aims to evaluate the effectiveness and safety of Tegileridine and Oliceridine injections in managing postoperative pain, focusing on the difference in resting pain scores within 24 hours after starting the treatment.

What is being tested

Tegileridine

+ Oliceridine

+ Morphine

Drug
Who is being recruted

Agnosia+4

+ Nervous System Diseases

+ Neurologic Manifestations

From 18 to 70 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorYuwei Qiu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 3, 2024

Actual date on which the first participant was enrolled.

The study focuses on testing two medications, tegileridine and oliceridine, to see how well they work and how safe they are for treating pain after surgery. It targets Chinese patients who are experiencing pain following surgical procedures. The research aims to find better ways to manage pain after surgery, which is a common and challenging issue for patients recovering from operations. By understanding how these drugs perform, the study hopes to improve pain relief options and enhance patient comfort during the recovery period. Participants in the study receive either tegileridine or oliceridine through injections. The study observes and records how effective each drug is at reducing pain and monitors any side effects. This approach helps in determining the safety and efficacy of these medications in real-world settings. The study does not include specific outcome measures in its description, but it is implied that patient comfort and drug safety are key areas of assessment.

Official TitleTo Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
NCT06458400
Principal SponsorYuwei Qiu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AgnosiaNervous System DiseasesNeurologic ManifestationsPerceptual DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Criteria

6 inclusion criteria required to participate
Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h;
18 years old ≤ age ≤70 years old, regardless of gender;
18 kg/m2≤BMI≤30 kg/m2;
American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;
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10 exclusion criteria prevent from participating
Patients with a previous history of difficult airway (obstructive sleep apnea syndrome), severe respiratory depression such as oxygen saturation < 90%, or a history of acute or severe bronchial asthma;
Patients with a history of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina pectoris, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or ischemic stroke in NYHA class Ⅱ or above);
Known or suspected gastric bowel obstruction, including paralytic ileus patients;
Patients with allergy to opioids or any component of the trial drug;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The loading iv dose: 0.75mg The PCIA dose：0.05mg Lockout time: 10min

Group II

Experimental
The loading iv dose: 1.5mg The PCIA dose：0.35mg Lockout time: 6min

Group III

Active Comparator
The loading iv dose: 3mg The PCIA dose：1mg Lockout time: 6min

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

241 Huaihai West Road, Xuhui District, Shanghai

Shanghai, ChinaOpen 241 Huaihai West Road, Xuhui District, Shanghai in Google Maps
CompletedOne Study Center