None
Conditions
Interventions
Experimental Group:Thirty minutes before the start of surgery, a loading dose of Anrikefon at 1.0 µg/kg, diluted in 10 mL of 0.9% normal saline, will be administered intravenously over more than 2 min
Control group:30 minutes before surgery, butorphanol 6.0 µg/kg was administered intravenously as a loading dose (based on the equivalent dose conversion of remifentanil and morphine). After surgery, t
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, no gender restriction; 2. Patients scheduled for elective laparoscopic cholecystectomy; 3. ASA score I–III; 4. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Expected hospital stay <48 hours; 2. Patients expected to enter the ICU postoperatively; 3. Patients expected to require mechanical ventilation support postoperatively; 4. Known allergy to the active ingredient or excipients of Enricfen injection; 5. Patients with severe consciousness disorders or mental illnesses (schizophrenia, mania, bipolar disorder, psychosis, etc.) and cognitive impairment; 6. History of serious cardiovascular disease (such as congestive heart failure, severe angina attacks, or unstable angina or myocardial infarction within the past 6 months); 7. Pregnant or breastfeeding patients; 8. Patients with an MMSE score <18; 9. Patients with poorly controlled or untreated hypertension (arterial hypertension with resting systolic blood pressure over 180 mmHg or resting diastolic blood pressure over 100 mmHg); 10. Untreated or inadequately treated hyperthyroidism; 11. Recent opioid abuse history (e.g., within the past 3 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale (NRS) pain scores within 48 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total opioid consumption within 48 hours postoperatively (converted to morphine-equivalent dose);; Time to first rescue analgesic administration and its incidence after surgery;Time to emergence from anesthesia;Incidence of intraoperative adverse events; | — |
Countries
China
Contacts
Public ContactMuhuo Ji
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed