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Effect of Preventive Analgesia with Tapentadol Fumarate on the Incidence of Postoperative Nausea and Vomiting in High-Risk Patients Undergoing Thyroid and Breast Surgery: A Prospective, Double-Blind, Positive-Controlled Trial

Effect of Preventive Analgesia with Tapentadol Fumarate on the Incidence of Postoperative Nausea and Vomiting in High-Risk Patients Undergoing Thyroid and Breast Surgery: A Prospective, Double-Blind, Positive-Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107564
Enrollment
Unknown
Registered
2025-08-14
Start date
2025-08-30
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

breast nodules and thyroid nodules

Interventions

Tagilidine fumarate group(Group T):The postoperative analgesic drug is tapentadol fumarate at a dose of 0.01mg/kg.
Hydromorphone group (Group H, positive control group):The postoperative analgesic drug is hydromorphone at a dose of 0.015mg/kg.

Sponsors

Guangzhou Institute of Cancer Research,the Afliated Cancer Hospital, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1, Aged 18 to 65 years; 2.Patients undergoing modified radical mastectomy, breast-conserving surgery, or partial/total thyroidectomy under tracheal intubation general anesthesia; 3.Apfel simplified risk score (PONV risk score) >= 3 points (i.e., high-risk patients); 4.ASA physical status ?-?; 5.Body mass index (BMI) >= 18 kg/m^2 and <= 30 kg/m^2; 6. Patients voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with chronic pain, alcoholism, or drug dependence; 2.Patients taking sedatives, analgesics, or antidepressants before surgery; 3. Patients with allergies to this drug or opioids; 4.Patients with severe preoperative respiratory diseases such as bronchial asthma, COPD, etc.; 5.Patients with other severe preoperative systemic diseases and an ASA physical status of III or higher; 6.Patients with preoperative cognitive impairment, who are expected to have difficulty completing assessments related to outcome indicators; 7.Patients currently participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative nausea and vomiting (defined as mild nausea with or without vomitus);

Secondary

MeasureTime frame
QoR-15 score at 24 hours after surgery;po24h NRS score;Perioperative opioid consumption;time to first ambulation;duration of drainage tube indwelling and postoperative hospital stay duration;

Countries

China

Contacts

Public ContactYao Yonghua

Guangzhou Institute of Cancer Research,the Afliated Cancer Hospital, Guangzhou Medical University

yaoyonghua01@126.com+86 20 6667 3666

Outcome results

None listed

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