Analgesia
Conditions
Keywords
Analgesia, Biased μ-opioid receptor agonists
Brief 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.
Interventions
DRUGTegileridine
single dose+PCA dose
DRUGOliceridine
single dose+PCA dose
DRUGMorphine
single dose+PCA dose
Sponsors
Yuwei Qiu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion | during the first 24 hours after starting a loading dose of test drug infusion | resting pain score is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion | Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose | exercise-state pain score is assessed by Numeric Rating Scale, range 0-10, 0=no pain and |
| total pain relief (TOTPAR) scores | 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose | Time-weighted sum of resting and moving state pain relief scores |
| the percentage of patients receiving rescue analgesia | from 0-24 hours after the first loading dose | the percentage of patients receiving rescue analgesia |
| length of bed stay | From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months. | length out of bed |
| Length of hospital stay | From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months. | postoperative length of hospital stay |
| Resting-state pain and exercise-state pain intensity | Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose | Resting-state pain and exercise-state pain intensity are assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain |
| incidence rate of respiratory depression | the first 24 hours after surgery | respiratory depression is defined as respiratory rate \< 8 and/or SpO2\<90% |
| analgesia satisfaction | the first 24 hours after surgery | satisfaction evaluation using 0-100 scale |
| pressing times of postoperative analgesic pump | the first 24 hours after surgery | — |
| total doses of postoperative analgesic pump | the first 24 hours after surgery | — |
| incidence of Postoperative nausea and vomiting | the first 24 hours after surgery | incidence rate of PONV |
Countries
China
Outcome results
None listed