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Efficacy and Safety Between Tegileridine and Sufentanil in Laparoscopic Surgery Patients at High Risk of Postoperative Nausea and Vomiting

NCT07691086 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2026-07-08

No results posted yet for this study

Summary

Postoperative nausea and vomiting (PONV) is one of the most common and distressing perioperative adverse events in patients undergoing laparoscopic surgery.1 Although laparoscopic procedures are minimally invasive, PONV can still occur in 30%-60% of cases due to factors such as insufflation-induced stimulation, vagal nerve activation, and the use of perioperative opioids, with rates exceeding 70% in high-risk populations.2,3 PONV not only significantly reduces patient comfort and satisfaction but may also lead to wound dehiscence, electrolyte imbalances, aspiration, delayed oral intake, and reduced mobilization-thereby contradicting the principles of enhanced recovery after surgery (ERAS).3

The Apfel score is currently the most widely used and practical clinical tool for assessing PONV risk.4 Patients scoring ≥3 on the Apfel scale are considered at high risk for PONV, and guidelines recommend multimodal analgesia and multi-route preventive strategies to minimize opioid-related adverse effects.4

Tegileridine fumarate injection (Tegileridine, trade name: Aisute) is a novel μ-opioid receptor-biased agonist.5 Unlike traditional opioids, tegileridine primarily activates G protein-coupled signaling pathways to exert analgesic effects while minimizing activation of the β-arrestin-2 pathway, which is closely associated with adverse reactions such as respiratory depression and nausea/vomiting.5,6 Previous clinical studies have shown that tegileridine provides effective pain relief for moderate to severe postoperative pain, with a potentially lower incidence of PONV compared to conventional opioids.

However, clinical evidence regarding the effectiveness and safety of a single intravenous dose of tegileridine administered at the end of surgery for pain transition in Apfel high-risk patients undergoing laparoscopic surgery remains limited. Therefore, it is necessary to systematically evaluate this analgesic strategy in real-world clinical settings to provide robust evidence-based support for clinical practice.8

This study aims to assess, in patients undergoing laparoscopic surgery with an Apfel score ≥3, the following outcomes of a single intravenous administration of tegileridine fumarate at the end of surgery: 1) analgesic efficacy; 2) incidence and severity of PONV within 24 hours postoperatively; and 3) occurrence of other perioperative adverse events, including pruritus, respiratory depression, and dizziness. The findings will provide clinical guidance for postoperative pain management and prevention of adverse events in high-risk PONV patients undergoing laparoscopic surgery.

Conditions

  • Postoperative Nausea and Vomiting (PONV)
  • Enhanced Recovery After Surgery
  • Laparoscopic Surgery

Interventions

DRUG

analgesic drugs and methods

single intravenous injection of Tegileridine or sufentanil after the operation

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-06-30
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691086 on ClinicalTrials.gov