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A prospective, single-center, blinded, randomized controlled trial comparing the effects of tegilildine and sufentanil on postoperative analgesia in patients undergoing gynecological laparoscopic surgery

A prospective, single-center, blinded, randomized controlled trial comparing the effects of tegilildine and sufentanil on postoperative analgesia in patients undergoing gynecological laparoscopic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117728
Enrollment
Unknown
Registered
2026-01-28
Start date
2026-03-02
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Postoperative pain in patients undergoing gynecological laparoscopic surgery

Interventions

Tegileridine Group (Group T):Single intravenous injection: 0.015 mg/kg
PCIA background infusion rate: 0.004 mg/(kg·h)
Sufentanil Group (Group S):Single intravenous injection: 0.15ug/kg
PCIA background infusion rate: 0.04 µg/(kg·h)

Sponsors

The First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Aged 20 to 60 years; 2.American Society of Anesthesiologists (ASA) physical status classification I–III; 3.Body mass index (BMI) 18–30 kg/m²; 4.Scheduled to undergo elective gynecological laparoscopic surgery; 5.Requiring postoperative intravenous analgesia; 6.Voluntary participation in the study and provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients had a history of intolerance to postoperative patient-controlled intravenous analgesia or a history of adverse events of postoperative patient-controlled intravenous analgesia; 2. Clear allergic history to sufentanil, tiglilidine and other opioids, propofol, muscle relaxants, flurbiprofen axetil, tropisetron, etc. 3. Severe cardiovascular disease: including severe uncontrolled hypertension (systolic blood pressure>=180mmHg and/or diastolic blood pressure >=100mmHg without antihypertensive drug treatment; After regular antihypertensive treatment, systolic blood pressure is still > 160 mmHg and/or diastolic blood pressure is still > 100mmHg), severe arrhythmia, corrected QT interval (QTc) > 470ms, heart failure, unstable angina pectoris, third degree atrioventricular block, sick sinus syndrome, history of myocardial infarction within the past 6 months; 4. Severe respiratory diseases: including acute exacerbation of chronic obstructive pulmonary disease, active bronchiectasis, acute exacerbation of bronchial asthma, respiratory failure, etc. 5. In the acute stage of cerebrovascular accident (cerebral hemorrhage or cerebral infarction within 3 months); 6. Combined with liver failure or renal failure; 7. Preoperative hypokalemia (serum potassium concentration 5.5 mmol/L); 8. Continuous use of sedative, hypnotic and analgesic drugs (such as diazepam, dexzopicolone tablets, etc.) and antipsychotic drugs (such as risperidone, olanzapine, fluoxetine, paroxetine, etc.) in the past 3 months; 9. There were communication disorders, including hearing impairment, language comprehension disorder, mental illness, etc., and they were unable to cooperate with the follow-up; 10. After comprehensive evaluation by the investigators, it was determined that it was not suitable for inclusion in this clinical study.

Design outcomes

Primary

MeasureTime frame
VAS pain score;Duration of analgesia after a single dose;

Secondary

MeasureTime frame
Number of PCIA bolus presses within 48 hours;Rescue analgesic use rate;VAS score for PONV;Antiemetic use rate;Incidence of respiratory depression;Incidence of somnolence;Incidence of skin pruritus;Incidence of dizziness;First flatus time;Postoperative length of stay;Quality of Recovery;Patient and nursing staff satisfaction;

Countries

China

Contacts

Public ContactJing Luo

The First People's Hospital of Yunnan Province

2292940670@qq.com+86 180 8798 8614

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026