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

Официальное название

Efficacy and Safety Between Tegileridine and Sufentanil in Laparoscopic Surgery Patients at High Risk of Postoperative Nausea and Vomiting: A Prospective Observational Cohort Study

Обзор

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.

Вмешательства

• Препарат analgesic drugs and methods
  single intravenous injection of Tegileridine or sufentanil after the operation

Первичные конечные точки

• postoperative nausea and vomiting within 24 hours aftre surgery [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

• Age: 18-75 years old ASA classification: I-III grade Received elective laparoscopic surgery (such as gynecological and general surgical laparoscopic surgeries) Apfel score ≥ 3 points Preoperative NRS pain score ≤ 3 points Did not use postoperative analgesic pump (PCA)

Критерии исключения

• BMI ≥ 30 kg/m² Allergic to opioids or study drugs History of chronic pain or long-term use of opioids Severe liver or kidney dysfunction Requires transfer to ICU after surgery Severe respiratory disease or SpO₂ < 90% Pregnant or lactating women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07691086 · 2026-0570

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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