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Not Yet RecruitingNCT07353983

Pharmacokinetic Evaluation of Anrikefon Injection in the Geriatric Population With the Management of Acute Pain Following Abdominal Laparoscopy

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

This study used a single-center, single-arm, pharmacokinetic ( PK ) study design. Thirty subjects who met the inclusion criteria were stratified according to age, including 15 in each age group of 65-74 years old and ≥ 75 years old. The patients were treated with a unified anesthesia method during abdominal endoscopic surgery. Anrecofin injection 1.0 μg / kg was injected for the first time within 15 min, and then once again at 8 h and 16 h. And received 6 pain assessments, 1 satisfaction score and 1 telephone follow-up. In this study, 10 blood samples were collected and analyzed.

Conditions

Interventions

TypeNameDescription
DRUGInject Anrikefon InjectionAfter the end of the operation ( the end of the last needle suture ), the researchers need to give the subjects 1.0μg / kg of Anrikefon Injection for the first time as soon as possible ( within 15 minutes ) ( 1ml of Anrikefon Injection stock solution was diluted to 10ml, and then the dose was calculated according to the body weight, and the corresponding volume was extracted, and the injection was completed in about 2 minutes ).

Timeline

Start date
2026-01-01
Primary completion
2026-01-22
Completion
2027-12-31
First posted
2026-01-21
Last updated
2026-01-21

Source: ClinicalTrials.gov record NCT07353983. Inclusion in this directory is not an endorsement.