surgical pain
Conditions
Interventions
control group:intravenous once analgesics sufentanil after surgery
treatment group:intravenous once analgesics oliceridine after surgery
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. age>=18 years; male or female 2. ASA I-III 3. undergoing intubation anasthesia; moderate to severe post-surgery pain needing opioids or non-opioids treatment 4. anticipated operation time = 1 h; cariovascular and craniocerebral operations excluded elective surgery 5. understaning VAS score 6. BMI 18 ~ 30 kg/m^2, boundary value included 7. screening period: respiratory rate between 10 and 24; pulse oxygen saturation >=95%; SBP between 90 and 160mmHg; DBP between 60 and 100mmHg; HR between 55 and 100bpm 8. able to understan this study procedure and methods; willing to obey trial and sign informed consent
Exclusion criteria
Exclusion criteria: 1. unconsciousness or limited autonomous awareness 2. combination of local anasthesia 3. non-incision surgery, eg. transurethral lithotripsy 4. hemorrhoea; convert to thoracotomy or laparotomy 5. contraindications to general anesthesia or previous history of anesthesia accidents ;history of other systems increasing risks of anesthesia 6. known or suspected family history of malignant hyperthermia 7. known or suspected to be allergic to or contraindicated in the routine administration of each component or protocol of the investigational drug, suspected of epilepsy or severe hepatic or renal insufficiency 8. Predicted difficulty in intubation or ventilation (modified Mallampati score III, IV) 9. screeing period company any of following airway management risk:1) history of asthma, wheezing; 2) with sleep apnea syndrome 10. investigator insisting any inappropriate situation inable subjects joining 11. chronic pain (3 months) or chronic analgesic use (3 months) 12. current or past drug addiction 13. Prior to screening, any of the following drugs or treatments were used: 1) Participants in any drug clinical trial within 1 month prior to screening; 2) Drugs that may affect the QT interval were used within 2 weeks prior to screening; The laboratory examination indexes reached the following standards: 1) AST and ALT >= 3×ULN; 2) TBIL >=1.5×ULN; 3) Hb=1.5×ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS scale;Analgesic drug demand; | — |
Secondary
| Measure | Time frame |
|---|---|
| PACU analgesic bridging safety;Consciousness score after administration of analgesic drugs;PACU dwell time after administration; | — |
Countries
China
Contacts
Public ContactHe Jianbin
Shenzhen People's Hospital
Outcome results
None listed