Efficacy of Oxalidine and Sufentanil in Strabismus Correction

NCT ID: NCT07112157

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Oliceridine group

After entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction

Group Type: EXPERIMENTAL

Oliceridine

Intervention Type: DRUG

After entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction

Sufentanil group

After the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg

Group Type: ACTIVE_COMPARATOR

Sulfentanil

Intervention Type: DRUG

After the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg

Interventions

Oliceridine

After entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction

Intervention Type: DRUG

Sulfentanil

After the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patients to be treated with strabismus correction under general anesthesia are 3-60 years old, regardless of gender.

The American Society of anesthesiologists (ASA) classification is Ⅰ - Ⅱ. Patients or their guardians (for child patients) voluntarily participated in the trial and signed the informed consent form with informed consent.

Exclusion Criteria

• Those who are allergic to oxalidine, sufentanil or any of the ingredients in their preparations.

Patients with severe heart, liver, kidney and other important organ dysfunction.

Have a history of epilepsy or central nervous system disease. Other opioid analgesics were used within 48 hours before operation. Pregnant or lactating women. Patients with mental disorders who are unable to cooperate to complete the test related assessment.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ningning Fu

Role: CONTACT

736508728@qq.com

8618790658707

Other Identifiers

HenanPPH-FNN3

Identifier Type: -

Identifier Source: org_study_id