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A Randomized, Double-Blind, Placebo-Controlled Trial of Anrikefon for Postoperative Analgesia After Percutaneous Nephrolithotomy
Sponsor: Beijing Tsinghua Chang Gung Hospital
Summary
This study evaluates whether a single dose of anrikefon, given intravenously shortly before the end of kidney stone removal surgery (PCNL), can reduce opioid-related side effects such as nausea, vomiting, itching, oversedation, and breathing problems in the first 24 hours after surgery. All participants receive the same standard pain control regimen (flurbiprofen axetil plus a sufentanil patient-controlled pump). In addition, half receive anrikefon and half receive a placebo (saline), decided by random allocation, with neither patients nor doctors knowing who receives which. A total of 160 adults (18-75 years) undergoing elective PCNL at Beijing Tsinghua Changgung Hospital will take part. Pain scores, opioid use, recovery, satisfaction, kidney function and side effects will be followed for up to 3 days after surgery.
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of Anrikefon for Perioperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-10-12
Completion Date
2029-12-30
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
0.9% Sodium Chloride Injection as Placebo
5 mL IV, administered 15-30 min before the end of surgery; identical in appearance to anrikefon; used as placebo comparator.
Anrikefon
Single IV dose of anrikefon 0.1 mg diluted to 5 mL with 0.9% saline, administered 15-30 min before the end of surgery.