Skip to content

Clinical study for the efficacy and safety of naborphine and sufentanil in the prevention of visceral pain after gynecological laparoscopic surgery: a random, double-blind and parallel control study

Clinical study for the efficacy and safety of naborphine and sufentanil in the prevention of visceral pain after gynecological laparoscopic surgery: a random, double-blind and parallel control study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025076
Enrollment
Unknown
Registered
2019-08-10
Start date
2019-09-01
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Postoperative analgesia

Interventions

A:naborphine 1 mg/kg + Sufentabil 1 µg / kg
B:naborphine 1 mg/kg + sufentanil 2 mg/kg
C:naborphine 1 mg/kg + sufentanil 3 mg/kg
D:naborphine 2 mg/kg + sufentanil 1 mg/kg
E:naborphine 2 mg/kg + sufentanil 2 mg/kg
F:naborphine 2 mg/kg + sufentanil 3 mg/kg

Sponsors

Guangdong Medical University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The gynecological peritoneoscope under general anesthesia of the optional tracheal intubation, patients who are expected to need treatment with 24 H or more automatic venous analgesia pump(moderate and severe pain) after surgery; 2. ASA health status classification I to II; 3. 18 kg/m2 < BMI < 30 kg/m2; 4. Aged 18 to 70 years hospitalized female patients; 5. There is no obstacle to intravenous infusion; 6. Voluntary participation and signature of informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of head trauma, intracranial surgery, or stroke, or patients with organic lesions and mental disorders of the central nervous system during the 4 weeks before surgery; 2. Patients who need to enter the surgical intensive care unit(SICU) after surgery; 3. Patients with high bleeding risk, including patients with congenital hemorrhage disease(such as hemophilia), thrombocytopenia(platelet count less than 100x10^9/L) or patients with abnormal platelet function, and coagulation dysfunction(PT or APTT is higher than the normal value upper limit); 4. Previously, there was a clear history of cardiovascular disease, liver(ALT or AST > 1.5 times the normal limit), kidney(Cr > normal limit) abnormal function, endocrine system and other serious primary diseases; Patients with mental illness or speech disorders, inability to understand sedation scores, and VAS scores; 5. Patients with high blood pressure of level 2 and above (SBP >= 160 mmHg or DBP >= 100 mmmHg) or those who take ACEI and diuretics for 30 days or more; 6. Patients with perioperative pain after coronary bypass surgery (CABG); 7. Patients with a history of asthma and heart failure, and patients who have undergone organ transplantation; 8. Acetaminophen was used in 6h before the operation, or non-steroidal anti-inflammatory drugs (NSAIDs) were used in 12h; Other analgesics were used in 24 H before surgery; 9. Patients who are taking drugs which are interacting with the experimental drug to increase toxicity; 10. Patients who are allergic to experimental drugs; 11. Patients who were dependent on narcotic drugs or tolerated opioids before entering the group; 12. Patients who participated in other clinical studies before surgery in March; 13. Patients in other situations that the researchers believe are not suitable for participation.

Design outcomes

Primary

MeasureTime frame
Number and total dosage of tramadol, a remedial analgesic, within 24 hours after operation ;

Secondary

MeasureTime frame
The degree of pain;

Countries

China

Contacts

Public ContactXiaoxia Gu

Guangdong Medical University Affiliated Hospital

gu7450210@163.com+86 13729030217

Outcome results

None listed

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