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NCT07801183
Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy
Conditions: Postoperative Acute Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 117
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Location: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Guangzhou Guangdong
Summary
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Eligibility Criteria
Inclusion Criteria:
* Aged ≥ 18 years;
* American Society of Anesthesiologists (ASA) physical status classification I-III;
* Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;
* Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;
* Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion Criteria:
* Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;
* Patients undergoing emergency surgery or trauma patients;
* Intraoperative conversion to open laparotomy;
* History of abdominal surgery within the past 3 months;
* Patients undergoing liver transplantation or with metastasis to other organs;
* Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs;
* Severe renal dysfunction (estimated glomerular filtration rate \
Source: ClinicalTrials.gov (NCT07801183). StuddyBuddy aggregates publicly available trial information.