Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-01-09 @ 11:42 PM
Study NCT ID:
NCT07269106
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery
Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Organization:
Study Overview
Official Title:
Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery: A Multicenter, Randomized, Parallel-Control, Non-Inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if Anrikefon works as well as nalbuphine to control postoperative pain in adults undergoing ophthalmic surgery under general anesthesia. It will also learn about the safety and recovery outcomes of using Anrikefon.
The main questions it aims to answer are:
* Does Anrikefon provide pain relief that is not inferior to nalbuphine after ophthalmic surgery?
* Does Anrikefon cause fewer central side effects, such as sedation or dizziness, compared with nalbuphine?
* Does Anrikefon help patients recover and get discharged faster after day-surgery procedures? Researchers will compare Anrikefon to nalbuphine to see if Anrikefon can offer effective and safer perioperative analgesia for ophthalmic day-surgery patients.
Participants will:
* Receive either an intravenous dose of Anrikefon or nalbuphine during surgery.
* Be monitored for pain scores, side effects, and recovery parameters after surgery.
* Complete follow-up assessments.
The main questions it aims to answer are:
* Does Anrikefon provide pain relief that is not inferior to nalbuphine after ophthalmic surgery?
* Does Anrikefon cause fewer central side effects, such as sedation or dizziness, compared with nalbuphine?
* Does Anrikefon help patients recover and get discharged faster after day-surgery procedures? Researchers will compare Anrikefon to nalbuphine to see if Anrikefon can offer effective and safer perioperative analgesia for ophthalmic day-surgery patients.
Participants will:
* Receive either an intravenous dose of Anrikefon or nalbuphine during surgery.
* Be monitored for pain scores, side effects, and recovery parameters after surgery.
* Complete follow-up assessments.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: