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Safety and Efficacy of Oliceridine intravenous self-controlled analgesia in patients undergoing thoracoscopic lobectomy

Safety and Efficacy of Oliceridine intravenous self-controlled analgesia in patients undergoing thoracoscopic lobectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105283
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Lung diseases

Interventions

Group M:Loading dose: 4 mg (4ml). Postoperative PCA: Morphine 50 mg+ normal saline (NS) =100 ml. Compression volume: 1mg. Locking time: 6 min. Limit: 8 mg/h
Group O1:Loading dose 1.5 mg (4 ml), postoperative PCA: oxelidine 35 mg+NS=100 ml, compression volume 0.1 mg, locking time 6min, limit 2 mg/h.
Group O2:Loading dose 1.5 mg (4 ml), postoperative PCA: oxelidine 35 mg+NS=100 ml, compression amount 0.35 mg, locking time 6min, limit 2 mg/h.
Group O3:Loading dose 1.5 mg (4 ml), postoperative PCA: oxelidine 35 mg+NS=100 ml, compression amount 0.5 mg, locking time 6 min, limit 2 mg/h.

Sponsors

The Second Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age 18~65 years old; 2) ASA grade I-III; 3)BMI18-30 kg/m^2; 4) Elective thoracoscopic lobectomy under general anesthesia is planned, and the subject agrees to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Severe lung diseases, such as chronic obstructive pulmonary disease, pleural effusion, asthma, pneumothorax, and previous history of chest surgery, etc. 2) Preoperative blood oxygen saturation =90%; 3) Those who have experienced unstable angina pectoris, myocardial infarction or heart failure within 3 months; 4) Any cerebrovascular accident has occurred within the past three months, such as stroke, transient ischemic attack, etc. 5) Those with severe abnormal liver and kidney functions; 6) Those who are unable to communicate due to neurocognitive dysfunction or language disorders before the operation; 7) Patients who are participating in other clinical trials; 8) Those who have contraindications or allergies to the test drug or other anesthetic drugs used during the test process; 9) Those who have received long-term opioid treatment or used any analgesics within 48 hours; 10) And other circumstances that anesthesiologists consider may interfere with the research results.

Design outcomes

Primary

MeasureTime frame
The main efficacy evaluation index: The response rate to the test drug at each time point within 48 hours after the administration of the loading dose.;

Secondary

MeasureTime frame
Secondary efficacy evaluation indicators: 1. Response rate to the test drug at each time point within 1 hour after the administration of the loading dose.;Safety evaluation index;The general condition of the patient, the time of extubation after the operation, the heart rate, blood pressure and blood oxygen saturation of the patient at the time of extubation and 5 minutes and 10 minutes after extubation;The time of the patient's first ambulation and the length of hospital stay;The sleep quality scores of the patients at 24 hours, 48 hours and 72 hours after the operation;The occurrence of pulmonary complications (PPCs) within 7 days after the operation of the patients;The QoR-15 scale scores of the patients 1 day before the operation, 24 hours, 72 hours after the operation, and on the day of discharge;The satisfaction of perioperative patients with pain management;

Countries

China

Contacts

Public ContactXianwen Hu

The Second Hospital of Anhui Medical University

huxianwen001@126.com+86 151 5515 9719

Outcome results

None listed

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