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Use of µ-opioid receptor biased agonist Tegileridine vs. Sufentanyl in laparoscopic surgery for post-operative analgesia: Effects on Post-operative nausea and vomiting, a randomized, controlled, blinded study (UTSPEP study)

Use of µ-opioid receptor biased agonist Tegileridine vs. Sufentanyl in laparoscopic surgery for post-operative analgesia: Effects on Post-operative nausea and vomiting, a randomized, controlled, blinded study (UTSPEP study)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110053
Enrollment
Unknown
Registered
2025-09-29
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and vomiting after laparoscopic surgery

Interventions

Sufentanil Group:Sufentanil PCIA
Tegilizumab Group:Tegileridine PCIA

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Planned elective laparoscopic surgery under general anesthesia, not performed during the daytime; 2. Age 18-70 years; 3. ASA physical status classification I-III; 4. BMI between 18 kg/m^2 and 30 kg/m^2; 5. Patients at moderate to high risk for PONV (Apfel score >= 2); 6. Postoperative analgesia using patient-controlled intravenous analgesia (PCIA); 7. Fully understand the purpose and significance of this study, voluntarily sign the informed consent form, and willingly comply with the study procedures.

Exclusion criteria

Exclusion criteria: 1.Patients who are allergic to any component of opioid drugs or investigational drugs; 2.Severe liver and kidney dysfunction: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >= 3 times the upper limit value, total bilirubin (TBIL) >= 3 times the upper limit value, and serum creatinine >= 1.5 times the upper limit value; 3.Those with impaired cognitive function, poor communication, or those who need continuous sedation after surgery and are unable to be evaluated; 4.The researchers believed that the subjects were not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
The incidence of PONV within 72 hours after surgery;

Secondary

MeasureTime frame
The severity of PONV;Postoperative pain score;The frequency and incidence of postoperative nausea and vomiting respectively;The use of remedial antiemetic drugs;First exhaust time;The first time to get out of bed and move around;Adverse events;Postoperative PCIA compression statistics;

Countries

China

Contacts

Public ContactGuo Chen

West China Hospital of Sichuan University

grace_chenguo@hotmail.com+86 18980601577

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026