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Effects of Anrikefon on Postoperative Nausea and Vomiting in High-Risk PONV Patients Undergoing Laparoscopic Gastrointestinal Surgery: A Multicenter Randomized Controlled Clinical Trial

Effects of Anrikefon on Postoperative Nausea and Vomiting in High-Risk PONV Patients Undergoing Laparoscopic Gastrointestinal Surgery: A Multicenter Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111408
Enrollment
Unknown
Registered
2025-10-30
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

The four risk factors in the Apfel risk score system are female sex, history of PONV or motion sickness, nonsmoking status, and postoperative opioid use. Gastrointestinal cancer patients presenting with at least three of these risk factors were included

Interventions

Anrikefon group:Anrikefon analgesia

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.aged 18-80 years; 2.ASA physical status of I-III; 3.Apfel simplified risk score for PONV >= 3;

Exclusion criteria

Exclusion criteria: 1.Central nervous system diseases: Subjects with conditions such as epilepsy, Parkinson's disease, or other CNS disorders that may cause nausea and vomiting, including but not limited to traumatic brain injury, intracranial space-occupying lesions, and intracranial aneurysms. 2.History of severe drug allergy: Subjects with a history of severe drug allergies or a known allergy to any of the protocol-specified study medications (e.g., Anruikefen, 5-HT3 receptor antagonists, or dexamethasone). 3.Severe renal impairment: Defined as a glomerular filtration rate (GFR) <= 30 mL/min. 4.Preoperative use of medications with known antiemetic properties: Use of such medications within 2 weeks prior to surgery. 5.Psychiatric disorders or inability to communicate. 6.Pregnant or lactating women. 7.Refused to participate in the study. 8.Underwent laparoscopic exploratory surgery only.

Design outcomes

Primary

MeasureTime frame
Incidence of Postoperative Nausea and Vomiting (PONV);

Secondary

MeasureTime frame
Incidence of Nausea ,Incidence of Vomiting;Proportion of patients using antiemetic medication;Time to First Flatus , Time to First Defecation , Time to First Ambulation;Respiratory depression incidence;24-hour Intravenous Fluid;Length of Hospital Stay,Patient Satisfaction;Postoperative Pathological Stage;Time to the first occurrence of either vomiting or antiemetic administration;QoR-15 Score;Proportion of subjects experiencing severe PONV;Pain Scores , Rescue Analgesia , Opioid Consumption;Clavien-Dindo Classification;EQ-5D-5L questionnaire;

Countries

China

Contacts

Public ContactXu Pingbo

Zhejiang Cancer Hospital

xupingboshanghai@163.com+86 180 1731 2996

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026