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Efficacy and safety of SHR8554 on postoperative pain in Thoracoscopic Lung Surgery

A Randomized, Double-blind, Positive Parallel-controlled, Multicenter Clinical Study of the Efficacy and Safety of SHR8554 Injection for Postoperative Analgesia in Thoracoscopic Lung Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101939
Enrollment
Unknown
Registered
2025-05-06
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

postoperative pain on thoracoscopic lung surgery

Interventions

C group:sufentanil 1.5µg/ml
E3 group:SHR8554 0.125mg/kg
E1 group:SHR8554 0.075mg/kg
E2 group:SHR8554 0.1mg/kg

Sponsors

The First People’s Hospital of Lianyungang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~85 years old (including the cut-off value), gender is not limited; 2. Body mass index (BMI): 18.0~30.0kg/m^2 (including cut-off value); 3. The American Society of Anesthesiologists (ASA) grades are rated I to III preoperatively; 4. Elective thoracoscopic lung surgery under general anesthesia; 5. Able to understand the purpose, process and scale scoring method of this trial, the subject can operate the PCIA equipment, and can communicate effectively with the investigator; 6. Subjects voluntarily participate in this trial and sign written informed consent;

Exclusion criteria

Exclusion criteria: 1. Those who know or suspect allergies or contraindications to the components of the investigational drug or other opioids or other drugs specified in the course of the trial; 2. Patients with severe cardiovascular disease, liver and kidney insufficiency, neuropsychiatric dysfunction, and those who cannot cooperate with pain assessment; 3. Those with a history of long-term chronic pain; 4. Patients with severe respiratory and circulatory failure during anesthesia surgery; 5. Voluntary withdrawal from this trial;

Design outcomes

Primary

MeasureTime frame
Difference in total pain intensity within 0~48h (SPID48);

Secondary

MeasureTime frame
Incidence of nausea and vomiting at 48 hours;Comparison of patients' global impression scores 48 hours after the first dose of study drug;Proportion of subjects using salvage medications;The number and dose of salvage medications used;Proportion of subjects with treatment failure due to inadequate analgesic efficacy;Time to first use of salvage medication;The total number of compressions and the number of effective compressions and the total compression dose of the PCIA pump during the 48-hour period;

Countries

China

Contacts

Public ContactXiaobao zhang

The First People’s Hospital of Lianyungang

hotdog100@163.com+86 18961322507

Outcome results

None listed

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