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

NCT07691086 | Not Yet Recruiting

• 1 other identifier: 2026-0570
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

enhanced recovery after surgery; Postoperative nausea and vomiting (PONV); laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tegileridine group

Patients who received a single intravenous injection of Tegileridine after the laparoscopic surgery

Drug: analgesic drugs and methods

sufentanil group

Patients who received a single intravenous injection of sufentanil after the laparoscopic surgery

Interventions

analgesic drugs and methods DRUG

single intravenous injection of Tegileridine or sufentanil after the operation

Tegileridine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing laparoscopic surgery

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Analgesics; Methods

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Investigative Techniques

Central Study Contacts

Min Yan

CONTACT

13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share