Efficacy of Oxalidine and Sufentanil in Strabismus Correction (strabismus)

Zhengzhou University

Status: Not yet enrolling

Conditions: Strabismus Surgery

Treatments: Drug: Sulfentanil; Drug: Oliceridine

Study type: Interventional

Funder types: Other

Identifiers

NCT07112157

HenanPPH-FNN3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 estimated patients

Sex: All

Ages: 3 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups

Oliceridine group

Experimental group

Description:

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

Treatment:

Drug: Oliceridine

Sufentanil group

Active Comparator group

Description:

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

Treatment:

Drug: Sulfentanil