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A randomized controlled trial of different doses of tegiletidine versus sufentanil for postoperative patient-controlled intravenous analgesia (PCIA) in patients with gynecological malignancies undergoing laparoscopic surgery

A randomized controlled trial of different doses of tegiletidine versus sufentanil for postoperative patient-controlled intravenous analgesia (PCIA) in patients with gynecological malignancies undergoing laparoscopic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120420
Enrollment
Unknown
Registered
2026-03-13
Start date
2026-03-18
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Postoperative Analgesia

Interventions

Group T1:Loading dose: Tegiletidine fumarate 1 mg was slowly administered via intravenous pump infusion 30 minutes before the end of surgery. PCIA regimen: Telitacicept fumarate 2.5 mg+ tropisetron 10
Group T2:Loading dose: Tegiletidine fumarate 1 mg was slowly administered via intravenous pump infusion 30 minutes before the end of surgery. PCIA regimen: Telitacicept fumarate 3 mg+ tropisetron 10 m
Group S:Loading dose: Sufentanil 3 µg was slowly administered via intravenous pump infusion 30 minutes before the end of surgery. PCIA regimen: Sufentanil 100 µg + tropisetron 10 mg + normal saline to

Sponsors

Affiliated Cancer Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18–65 years old; 2. Patients with gynecological malignancies scheduled for laparoscopic surgery; 3. American Society of Anesthesiologists (ASA) physical status classification ?–?; 4.Body mass index (BMI): 18.5 kg/m^2 < BMI < 30 kg/m^2; 5.Having a clear understanding of the study, voluntarily participating in the research, and providing written informed consent personally.

Exclusion criteria

Exclusion criteria: 1.Severe cardiovascular and cerebrovascular diseases: New York Heart Association (NYHA) functional classification >= ? or left ventricular ejection fraction (LVEF) = 160/100 mmHg; 3. A history of acute coronary syndrome or stroke within the previous 6 months; 4. Complicated by respiratory system diseases: patients with abnormal pulse oxygen saturation (SpO2) 7.5%; 8. Abnormal hepatic and renal function: Child-Pugh liver function score > 7, estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2; 9. A history of allergic diseases or hypersensitivity to the study drugs; 10. Pregnancy, lactation, or planned pregnancy in the near future; 11.Participation in other clinical trials of investigational drugs as a subject within the previous 3 months; 12.A history of alcoholism or substance abuse; 13.Presence of communication disorders, cognitive dysfunction, or mental illnesses, resulting in inability to cooperate with pain assessment.

Design outcomes

Primary

MeasureTime frame
Numeric Rating Scale Score;Total number of effective PCA presses within 48 hours postoperatively;Utilization rate and total consumption of rescue analgesics;

Secondary

MeasureTime frame
Respiratory rate;Bruggrmann Comfort Scale (BCS);Adverse reactions;I-FEED score;Patient satisfaction score;

Countries

China

Contacts

Public ContactLin Xiaofen

Affiliated Cancer Hospital of Guizhou Medical University

392737182@qq.com+86 182 8514 9556

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026