Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy

NCT07801183 | Not Yet Recruiting Phase 4

• 1 other identifier: SYSKY-2026-307-03
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Acute Pain

Keywords

postoperative acute pain; laparoscopic hepatectomy; Anrikefon

Outcome Measures

Primary Outcomes (1)

• Consumption of sufentanil via PCIA within 48 hours after the first study drug administration

  0-48 hours post first study drug dose

Secondary Outcomes (19)

• Proportion of rescue analgesia

  Within0-24 hours and 0-48 hours after the first study drug administration

• Cumulative consumption dose of rescue analgesia

  within 0-24 hours and 0-48 hours after the first study drug administration

• Time from end of surgery to first passage of flatus (hours)

  Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs

• Time from end of surgery to first defecation (hours)

  Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs

• Time from the end of surgery to first ambulation (hours)

  Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs

Study Arms (3)

Anruikefon 1 μg/kg per dose Group

EXPERIMENTAL

Anruikefon 1 μg/kg per dose, once every 8 hours (q8h), for a total of 6 doses.

Drug: Anruikefon 1 μg/kg per dose Group

Anruikefon 100 μg per dose Group

EXPERIMENTAL

Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.

Drug: Anruikefon 100 μg per dose Group

Placebo Group

PLACEBO COMPARATOR

0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Drug: Control group

Interventions

Anruikefon 1 μg/kg per dose Group DRUG

Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.

Anruikefon 1 μg/kg per dose Group

Anruikefon 100 μg per dose Group DRUG

Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.

Anruikefon 100 μg per dose Group

Control group DRUG

0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \<30 mL/min/1.73 m²);
• Laboratory findings or clinical evaluation indicating hypothyroidism or hypokalemia graded ≥ Grade 3 per CTCAE v6.0;
• Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation);
• Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours;
• Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial.
• Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects.
• Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups; Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Changzhen Shang

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changzhen Shang

CONTACT

+86-20-3407 0701; shchzh2@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: September 3, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)