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Efficacy and safety of Tegileridine Fumarate Injection for postoperative analgesia in video-assisted thoracoscopic surgery (VATS),a multicenter prospective randomized controlled clinical study

Efficacy and safety of Tegileridine Fumarate Injection for postoperative analgesia in video-assisted thoracoscopic surgery (VATS),a multicenter prospective randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121230
Enrollment
Unknown
Registered
2026-03-27
Start date
2026-03-27
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain of VATS

Interventions

Tegileridine Gruop:Slowly pump 0.75mg of Tegileridine injection and 0.05mg of PICIA each time within 10 minutes, with a locking time of 10 minutes.
Sufentanil Group:Slowly pump 3 µg of sufentanil injection and PICA1 µg each time within 10 minutes, with a locking time of 10 minutes.

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Scheduled for elective VATS lobectomy or segmentectomy under general anesthesia with endotracheal intubation, with an estimated surgical duration of 1-3 hours; 2. Aged >=18 years, regardless of gender; 3. Body Mass Index (BMI) between 18 and 30 kg/m²; 4. American Society of Anesthesiologists (ASA) physical status classification of I or II; 5. Voluntarily sign the informed consent form before any trial-related activities begin, fully understand the purpose and significance of this trial, and voluntarily comply with the trial procedures;

Exclusion criteria

Exclusion criteria: 1. Patients with a history of 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 or cerebrovascular diseases (such as myocardial infarction or unstable angina, or severe arrhythmias like grade II or higher atrioventricular block, or ischemic stroke of NYHA class II or above); 3. Patients with known or suspected gastrointestinal obstruction, including those with paralytic ileus; 4. Patients allergic to opioids or any component of the investigational drug; 5. Subjects with a history of mental illness (such as schizophrenia, depression, etc.) and cognitive dysfunction; 6. Patients with advanced malignant tumors or malignant tumor patients with extensive metastasis; 7. Subjects suffering from other somatic pain that may affect postoperative pain assessment; 8. Subjects with a history of drug, medication, and/or alcohol abuse within 1 year prior to randomization; 9. Female subjects who are pregnant or breastfeeding; 10. Subjects whom the investigator deems unsuitable for participation in the trial due to any other factors.

Design outcomes

Primary

MeasureTime frame
AUC-NRS48;

Secondary

MeasureTime frame
Adverse Drug Reaction (ADR) Evaluation;Analgesia satisfaction;Incidence of postoperative nausea and vomiting (PONV);Incidence of respiratory depression;

Countries

China

Contacts

Public ContactZhongyuan Xia

Renmin Hospital of Wuhan University

xiazhongyuan2005@aliyun.com+86 27 88041911

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026