NCT07112157

Efficacy of Oxalidine and Sufentanil in Strabismus Correction

Efficacy of Oxalidine and Sufentanil in Strabismus Correction: a Non Inferiority Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Henan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the anesthetic effect of oxalidine and sufentanil in strabismus surgery through a non inferiority test, including analgesic efficacy, intraoperative hemodynamic stability, postoperative recovery quality and the incidence of adverse reactions. . This study will provide a new evidence-based basis for the application of opioids in ophthalmic short surgery, and may improve the perioperative experience of patients.

Detailed description

Since surgery involves fine manipulation of the ocular muscles, postoperative pain and oculocardiac reflex (OCR) are common clinical challenges. Therefore, anesthesia management should not only ensure adequate analgesia, but also minimize stress reactions and adverse reactions caused by surgical stimuli. At present, opioids such as sufentanil are widely used in the anesthesia scheme of such surgery because of its potent analgesia and stable hemodynamic characteristics. However, sufentanil may cause respiratory depression, postoperative nausea and vomiting (PONV) and other side effects, and its high lipid solubility may prolong the postoperative recovery time. Oliceridine is a new selective μ - opioid receptor agonist. Compared with traditional opioids, it has the characteristics of biased activation of G protein pathway, which may provide effective analgesia and reduce the adverse reactions mediated by β - arrestin pathway (such as respiratory depression and gastrointestinal dysfunction). Recent studies have shown that oselidine has shown good safety and efficacy in postoperative analgesia, but its application in short ophthalmic surgery (such as strabismus correction) has not been fully explored.

Conditions

• Strabismus Surgery

Interventions

Type	Name	Description
DRUG	Oliceridine	After entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction
DRUG	Sulfentanil	After the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-08-08
• Last updated: 2025-08-08