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The Efficacy of Tegileridine versus Sufentanil in Preventing Postoperative Nausea and Vomiting after Gynecological Laparoscopic Surgery:A Randomized, Double-Blind, Controlled Trial

The Efficacy of Tegileridine versus Sufentanil in Preventing Postoperative Nausea and Vomiting after Gynecological Laparoscopic Surgery:A Randomized, Double-Blind, Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116664
Enrollment
Unknown
Registered
2026-01-13
Start date
2026-02-16
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

postoperative nausea and vomiting

Interventions

Sufentanil Group:Administer 5 µg of sufentanil intravenously 30 minutes before the end, and use sufentanil PCIA (100 µg/100 ml) for postoperative analgesia.
Tegileridine Group:Inject 0.5 mg of Tegileridine intravenously 30 minutes before the end of surgery, and use Tegileridine PCIA (5 mg/100 ml) for postoperative analgesia.

Sponsors

International Peace Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 to 65 years (inclusive); 2. Classified as ASA I to II by the American Society of Anesthesiologists, with physical condition capable of tolerating surgery and anesthesia; 3. Planning to undergo elective gynecological laparoscopic surgery under general anesthesia; 4. Fully understand the study content, voluntarily participate, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals known to have a history of allergy to sufentanil, Tegileridine, or any components of their formulations; 2. Individuals who have used opioid or non-opioid analgesics long-term before surgery (routine use >1 week), or those with a history of drug abuse; 3. Female patients who are pregnant or breastfeeding; 4. Individuals with uncontrolled severe mental illness or cognitive dysfunction, who are unable to cooperate with pain and recovery quality assessments; 5. Individuals with conditions that may interfere with the assessment of postoperative nausea and vomiting (PONV), such as uncontrolled gastrointestinal diseases (gastric ulcer, pyloric obstruction, etc.), severe liver function abnormalities (e.g., acute hepatitis), or vestibular dysfunction; 6. Situations judged by the investigator as otherwise unsuitable for participation in this clinical study (e.g., critical illness, communication barriers); 7. Patients or their legal representatives who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
The incidence of nausea and vomiting within 24 hours after surgery;

Secondary

MeasureTime frame
Severity of nausea, vomiting, and retching within 24 hours after surgery;Dosage of droperidol as rescue antiemetic after surgery;Numeric Pain Rating Scale (NPRS) scores ;Postoperative analgesia satisfaction;Dosage of oxycodone as rescue analgesic after surgery;15-item Quality of Recovery Score at 24 Hours Postoperatively and Its Change from Preoperative Baseline;Incidence of opioid-related adverse events;Time to first postoperative flatus;

Countries

China

Contacts

Public ContactJianwei Wang

International Peace Maternity and Child Health Hospital

wangjianwei_0219@163.com+86 139 1837 2706

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026