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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Surgery; Enhanced Recovery After Surgery; Postoperative Nausea and Vomiting (PONV)
• Intervention / Treatment: Drug: analgesic drugs and methods

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Min Yan; Phone Number: 13757118632; Email: zryanmin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing laparoscopic surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tegileridine group; Patients who received a single intravenous injection of Tegileridine after the laparoscopic surgery	Drug: analgesic drugs and methods; single intravenous injection of Tegileridine or sufentanil after the operation
sufentanil group; Patients who received a single intravenous injection of sufentanil after the laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea and vomiting within 24 hours aftre surgery	Based on the assessment of SPONVSS scale, if the scale ≥ 3, it is determined nausea and vomiting have occurred.	24 hours after surgery

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: laparoscopic surgery; Postoperative nausea and vomiting (PONV); enhanced recovery after surgery
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Investigative Techniques; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Analgesics; Methods
• Other Study ID Numbers: 2026-0570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No