Not Yet Recruiting

NCT Number: NCT07330063

Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy

Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection.

Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Gastrectomy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 不限, 300000, China

Location contact

Bin Ke

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged between 18 and 70 years old (inclusive).
American Society of Anesthesiologists (ASA) physical status classification Class I-III.
Body Mass Index (BMI) ranging from 18 kg/m² to 30 kg/m² (inclusive).
Patients scheduled for elective total laparoscopic distal gastrectomy for gastric cancer under general anesthesia, with surgical duration < 5 hours.
Surgical incision length < 8 cm.
Voluntarily agree to participate in the trial and sign the informed consent form.

Exclusion criteria

Patients undergoing emergency surgery or suffering from trauma.
Patients who undergo conversion to open surgery or laparoscopically assisted distal gastrectomy for gastric cancer during the operation.
Patients who refuse to receive Patient-Controlled Intravenous Analgesia (PCIA).
Patients with a history of prior abdominal surgery.
Patients expected to require prolonged endotracheal intubation after surgery.

Treatment and study plan

Anruikefen (Intravenous Bolus)

Drug

Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Anruikefen (Intravenous Infusion)

Drug

Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

Placebo Group

Drug

Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Primary outcomes

Total Consumption of Sufentanil via PCIA

Time frame: within 48 Hours after the First Administration Postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Ke

CONTACT

[email protected]

022-23340123-1061

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 9, 2026
Registry last updated: Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting