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Clinical study on the effect of nalmefen on postoperative sufentanil intravenous controlled analgesia and related adverse reactions

Clinical study on the effect of nalmefen on postoperative sufentanil intravenous controlled analgesia and related adverse reactions

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049353
Enrollment
Unknown
Registered
2021-07-31
Start date
2020-09-04
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Postoperative pain of pulmonary nodules

Interventions

control group:5mg tropisetron
N1 group:1ug/kg nalmefene
N2group:2ug/kg nalmefene

Sponsors

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 65 years; 2) Selective general anesthesia and VAST partial lung resection; 3) Postoperative sufentanil PCIA analgesia; 4) ASA I - II level; 5) BMI, 18 kg/m2 or and 30 kg/m2 or less; 6) Informed consent of patients.

Exclusion criteria

Exclusion criteria: 1) Preoperative history of chronic pain; 2) Preoperative elevated intracranial pressure, motion sickness, glaucoma, severe hypertension or other diseases causing nausea and vomiting; 3) Pregnancy or lactation; 4) Allergic history of anesthetic drugs and non-steroidal anti-inflammatory drugs; 5) Long-term use of opiates and drug addiction; 6) The patient was diagnosed with severe heart, lung and brain diseases, active heart disease, ischemic heart disease, coronary artery bypass surgery, peripheral artery/cerebrovascular disease, abnormal liver function (AST and ALT greater than 1.5 times the normal value), and abnormal renal function (serum creatinine and urea nitrogen more than 1.2 times the normal value). 7) Participate in other clinical trials or chemoradiotherapy within 4 weeks; 8) Active gastrointestinal ulcer or gastrointestinal bleeding, inflammatory bowel disease; 9) Cognitive or communication abnormalities as determined by the investigator; 10) Plan to be admitted to ICU after surgery.

Design outcomes

Primary

MeasureTime frame
Dosage of sufentanil in analgesia pump;

Secondary

MeasureTime frame
NumericalPainRating Scale;Postoperative nausea;Postoperative vomiting;Amount of analgesic medication;Antiemetic drug dosage;Ramsay sedation score;Time of first defecation;Pruritus;

Countries

China

Contacts

Public ContactXinchuan Wei

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

390626473@qq.com+86 18981830580

Outcome results

None listed

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