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The Safety and Efficacy of Anrikefon Injection for Postoperative Bridging Analgesia in Elective Abdominal Surgery: a multicenter, open-label, pragmatic randomized controlled trial

The Safety and Efficacy of Anrikefon Injection for Postoperative Bridging Analgesia in Elective Abdominal Surgery: a multicenter, open-label, pragmatic randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120516
Enrollment
Unknown
Registered
2026-03-16
Start date
2026-03-16
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Surgery

Interventions

Anrikefon group:At the end of the operation (+/- 5 min after the last stitch of skin suture), intravenous injection of anrikefon 1 µg/kg (recommended dose) was given.
Control group:At the end of surgery (+/- 5 min after the last stitch), patients received other conventional postoperative analgesic drugs (sufentanil injection 0.1 µg/kg or nalbuphine injection 0.2 mg

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Fully understand and voluntarily participate in this study and sign the informed consent form; 2. Subjects scheduled for laparoscopic surgery under general anesthesia, with the operation duration ranging from 0.5 to 3 hours; 3. Age between 18 and 70 years old, with no gender restrictions; 4. American Society of Anesthesiologists (ASA) classification levels I-III; 5. Body mass index (BMI) ranging from 18 kg/m^2 to 40 kg/m^2; 6. Able to understand the research process and communicate effectively with the researchers.

Exclusion criteria

Exclusion criteria: 1. Patients who are known or suspected to have contraindications or allergies to any of the drugs used in the trial; 2. Those who have other severe liver, kidney, cardiovascular, respiratory system diseases, metabolic system diseases, such as respiratory depression, severe liver dysfunction, shock, distant metastatic malignant tumors, as determined by the investigator to be unsuitable for participating in this trial; 3. Those who have been using hormone drugs, opioid analgesics for a long time, or other drugs used within 7 days before randomization and judged by the investigator to affect the analgesic effect, including but not limited to NSAIDs, monoamine oxidase inhibitors, glucocorticoids (except for inhalation and local application on skin and mucous membranes), opioid analgesics, sedatives, antiepileptic drugs, antidepressants, anticonvulsants, anti-anxiety drugs, local anesthetics, other drugs with analgesic effects, Chinese patent medicines, plasters, etc.; 4. Those who have a surgical history assessed by the investigator as interfering with the safety and efficacy assessment of the study, and/or plan to undergo other surgical procedures at the same time; 5. Those with central nervous system diseases such as cerebral ischemia, intracranial hypertension, cranial injury, epileptic seizures, or with mental system diseases such as schizophrenia, mania, mental confusion, severe depression; 6. Those with other pains, other physical pain conditions that may confuse the postoperative pain assessment, as determined by the investigator; 7. Those who are participating in other drug trials or have participated in other clinical studies during the research period; 8. Those who are expected to be transferred to the intensive care unit after the surgery and not entering the PACU; 9. Other situations that the investigator deems inappropriate for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Respiratory-related adverse events ;

Secondary

MeasureTime frame
Severity of respiratory-related adverse events;Postoperative nausea and vomiting;Postoperative pruritus;Postoperative pain score;Postoperative opioid-related adverse events;

Countries

China

Contacts

Public ContactLijian Chen

The First Affiliated Hospital of Anhui Medical University

chenlijian77@126.com+86 139 6669 9467

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026