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Prospective Clinical Study on the Use of Fumaric Acid Tigelidine for the Prevention of Nausea and Vomiting Following Gynecological Laparoscopic Surgery

Prospective Clinical Study on the Use of Fumaric Acid Tigelidine for the Prevention of Nausea and Vomiting Following Gynecological Laparoscopic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114103
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Postoperative care following gynaecological laparoscopy

Interventions

Experimental group:Anaesthetic induction was achieved using remimazolam tosylate 0.3–0.4 mg/kg, sufentanil 0.4–0.6 µg/kg, and rocuronium bromide 0.6–0.9 mg/kg. Intraoperatively, remimazolam tosylate 1
Control group:Anaesthetic induction was achieved using remimazolam tosylate 0.3–0.4 mg/kg, sufentanil 0.4–0.6 µg/kg, and rocuronium bromide 0.6–0.9 mg/kg. Intraoperatively, remimazolam tosylate 1–3 mg

Sponsors

Henan Univ,Huaihe Hosp
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18–65 years; 2. ASA physical status classification I–III (American Society of Anesthesiologists); 3. Elective gynaecological laparoscopic surgery (including myomectomy, ovarian cystectomy, hysterectomy, etc.); 4. Apfel simplified risk score >= 3 points (indicating high risk for PONV); 5. Voluntary participation in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe combined dysfunction of vital organs including heart, liver, and kidneys; 2. Long-term opioid use or chronic pain syndrome; 3. Known allergy to any medication used in the study; 4. History of substance abuse or alcohol dependence; 5. Pregnant or breastfeeding women; 6. Other circumstances deemed unsuitable for study participation by the investigator.

Design outcomes

Primary

MeasureTime frame
QoR-15;

Secondary

MeasureTime frame
Complete resolution rate of PONV within 24 hours post-surgery;PONV Severity Score;VAS;Use of anti-emetic and analgesic drugs during labour;Time of first ambulation;Initial venting time;First bowel movement;Length of stay, hospital charges;

Countries

China

Contacts

Public ContactXin Wenqi

Huaihe Hospital of Henan University

xwq_mzk@163.com+86 166 0378 1303

Outcome results

None listed

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