Efficacy and Safety Between Tegileridine and Sufentanil in Laparoscopic Surgery Patients at High Risk of Postoperative Nausea and Vomiting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: analgesic drugs and methods.
- Who it may be relevant to
- Registry conditions: Postoperative Nausea and Vomiting (PONV), Enhanced Recovery After Surgery, Laparoscopic Surgery. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety Between Tegileridine and Sufentanil in Laparoscopic Surgery Patients at High Risk of Postoperative Nausea and Vomiting: A Prospective Observational Cohort Study
Overview
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.
Interventions
- Drug analgesic drugs and methods
single intravenous injection of Tegileridine or sufentanil after the operation
Primary outcome measures
- postoperative nausea and vomiting within 24 hours aftre surgery [Time frame: 24 hours after surgery]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07691086 · 2026-0570