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Comparison of anrikefon and sufentanil for postoperative patient-controlled analgesia after laparoscopic gynecological surgery

Comparison of anrikefon and sufentanil for postoperative patient-controlled analgesia after laparoscopic gynecological surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123646
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Diseases related to undergoing gynecological laparoscopic surgery

Interventions

A Group:Loading dose of 0.1 ug/kg sufentanil + 1 ug/kg anrikefon
48-hour analgesic dose of 2 ug/kg + 6 ug/kg sufentanil
patient-controlled bolus of 2 ml with a lockout time of 15 min
B Group:Loading dose of 0.1 ug/kg sufentanil
48-hour analgesic dose of 2 ug/kg sufentanil

Sponsors

Anqing Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective gynecological laparoscopic surgery; 2. ASA physical status I-III; 3. Age 18-65 years; BMI 18-35 kg/m^2; 4. Ethical compliance, voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cardiac, pulmonary, hepatic, or renal dysfunction; 2. History of psychiatric disorders (e.g., dementia, schizophrenia) or long-term use of psychotropic medications, chronic analgesic use, alcoholism, or drug allergies; 3. Severe infection; 4. Inability to communicate due to language barriers, hearing impairment, or neurological deficits (e.g., stroke); 5. Preoperative PaO2 <60 mmHg or SpO2 <90%; 6. Participation in another clinical drug trial within the past 30 days.

Design outcomes

Primary

MeasureTime frame
Sufentanil consumption within 48 hours postoperatively in Group A versus Group B;

Secondary

MeasureTime frame
Incidence rate of adverse events (nausea, vomiting, pruritus, somnolence, respiratory depression) within 48 hours postoperatively;Number of rescue analgesic administrations and dose within 48 hours postoperatively;NRS scores at 0.5, 2, 6, 12, 24, and 48 hours postoperatively;Baseline demographic and clinical characteristics including age, sex, height, weight, ASA classification, and comorbidities;Safety outcomes including nausea, vomiting, pruritus, somnolence, and respiratory depression;

Countries

China

Contacts

Public ContactSun Linglu

Anqing Municipal Hospital

348092640@qq.com+86 159 5556 5806

Outcome results

None listed

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