To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain

TGRD-ANAL-PILOT-001

This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.

2024-06-06

2024-12-25

2024-12-31

Not yet recruiting

Early phase I

75

Inclusion Criteria: 1. Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h; 2. 18 years old ≤ age ≤70 years old, regardless of gender; 3. 18 kg/m2≤BMI≤30 kg/m2; 4. American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ; 5. Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; 6. Before starting trial-related activities, participants should voluntarily sign the informed consent form, fully understand the purpose and significance of this trial, and voluntarily abide by the trial procedures. Exclusion Criteria: 1. 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; 2. 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); 3. Known or suspected gastric bowel obstruction, including paralytic ileus patients; 4. Patients with allergy to opioids or any component of the trial drug; 5. Subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment; 6. With late-stage malignant tumors or with extensive metastasis of malignant tumor patients; 7. Subjects with other somatic pain that may affect postoperative pain assessment; 8. A history of drug, drug, and/or alcohol abuse within 1 year before randomization; 9. Pregnant or lactating female subjects; 10. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

2024-06-13