To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment o… (NCT06458400) | Clinical Trial Compass
CompletedPhase 4
To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
China75 participantsStarted 2024-07-03
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
✓. 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
✕. 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;
✕. Subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment;
What they're measuring
1
Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion
Timeframe: during the first 24 hours after starting a loading dose of test drug infusion