postoperative pain
Conditions
Interventions
Oliceridine group:Postoperative PCIA analgesia regimen — Total volume: 100 ml, dose of fumarate Acelotine injection: 20 mg (2 vials), prepared with physiological saline.
Sufentanil group:Postoperative PCIA analgesia regimen — Total volume: 100 ml, dose of citric acid sufentanil injection: 100 µg, prepared with physiological saline.
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-65 years (including both endpoints), with no restrictions on gender; 2) Patients undergoing elective laparoscopic cholecystectomy under general anesthesia, with surgery time = 1.5 hours and postoperative hospital stay = 24 hours; 3) American Society of Anesthesiologists (ASA) classification of I or II; 4) BMI: 18 kg/m² to 30 kg/m² (including both endpoints); 5) Subjects understand the purpose and procedures of this trial, voluntarily participate in this trial, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals with contraindications for general anesthesia or a history of anesthesia-related complications; 2) Known intolerance or allergy to propofol, rocuronium, opioids, neostigmine, atropine, or alkaloids from deadly nightshade; 3) Long-term (continuous or intermittent) use of benzodiazepine sedatives, opioid analgesics, or those who have used anesthetic analgesics within 24 hours or anesthetic drugs within 7 days prior to randomization; 4) History of elevated intraocular pressure (such as glaucoma) or penetrating eye injuries; 5) History of asthma; 6) Mental disorders (such as schizophrenia, mania, delirium) or cognitive dysfunction; 7) History of cranial or brain injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accidents, or central nervous system diseases; 8) History of severe cardiovascular conditions (such as myocardial ischemia, heart failure, or severe arrhythmias); unstable angina due to insufficient coronary blood supply, or myocardial infarction within the past 6 months; 9) Hypertensive patients with a systolic blood pressure still =160 mmHg and/or diastolic blood pressure still =90 mmHg after treatment with antihypertensive drugs; 10) Diabetic patients with unsatisfactorily controlled blood glucose levels (fasting blood glucose =11.1 mmol/L during screening); 11) Severe lipid metabolism disorders (such as triglycerides >5 mmol/L, diabetic dyslipidemia, familial hypercholesterolemia, lipoid nephrosis, acute pancreatitis with hyperlipidemia, etc.); 12) History of hyperthyroidism; 13) History of drug abuse within the last 2 years prior to screening; 14) History of alcohol abuse within the last 2 years prior to screening, defined as consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or acute alcohol intoxication or alcohol dependence; 15) Participation in any clinical trial in the last 3 months prior to screening (defined as receiving investigational drugs or placebo); 16) Those deemed by the researcher to have respiratory management difficulties (modified Mallampati score of IV); 17) Abnormal coagulation function (PT or PT-INR = 1.5 × ULN, APTT = 1.5 × ULN), or having a bleeding tendency (such as active gastrointestinal ulcers) or currently undergoing thrombolysis or anticoagulant therapy; 18) Anemia or thrombocytopenia (PLT = 80 × 10^9/L, HGB = 90 g/L); 19) Abnormal liver function [ALT and/or AST = 2 × ULN, TBIL = 1.5 × ULN]; 20) Abnormal kidney function (BUN = 1.5 × ULN; Cr = 1.5 × ULN); 21) Known or suspected gastrointestinal obstruction, including paralytic ileus; 22) Any other factors deemed by the investigator as inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analgesic score within 48 hours after surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time of the first PCA press.;The time of the first use of rescue analgesics.;Cumulative dose of PCA;Degree of Patient Sedation;Occurrence of adverse reactions;Sleep quality of patients;postoperative recovery degree score;patient satisfaction rate; | — |
Countries
China
Contacts
Public ContactZheng Xiaochun
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed