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NCT Number: NCT07112157

Efficacy of Oxalidine and Sufentanil in Strabismus Correction

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oliceridine

Drug

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

Sulfentanil

Drug

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

Primary outcomes

  1. Adequate rate of intraoperative analgesia

    Time frame: From enrollment to the end of treatment at 1 day

    Definition: No body movement (body movement score ≤ 1) and no need for additional analgesics during surgical skin cutting and eye muscle traction.

    Evaluation method:

    Physical activity score (0-3 points): 0=none; 1=Mild (does not interfere with surgery); 2=Obvious (requiring intervention); 3=Severe (pause surgery).

  2. Success rate of initial insertion of laryngeal mask

    Time frame: From enrollment to the end of treatment at 1 day

    One time insertion of laryngeal mask without adjustment/replacement, and good airway sealing (normal ETCO ₂ waveform)

Secondary outcomes

  1. Ocular Heart Reflex (OCR) incidence rate

    Time frame: From enrollment to the end of treatment at 1 day

    HR decline>20% may require atropine intervention.

  2. Hemodynamic fluctuations

    Time frame: From enrollment to the end of treatment at 1 day

    Hypotension (MAP<65 mmHg or decrease from baseline>30%), hypertension (MAP>100 mmHg)

  3. Respiratory inhibition:

    Time frame: From enrollment to the end of treatment at 1 day

    SpO ₂<90% or ETCO ₂>50 mmHg

  4. Postoperative nausea and vomiting (PONV) (0-24h)

    Time frame: From enrollment to the end of treatment at 1 day

    Rating: 0=none; 1=Mild (no need for treatment); 2=Moderate (requires antiemetic medication); 3=Severe (repeated vomiting)

Study contacts

Contact information is provided by the study sponsor or research team.

Ningning Fu

CONTACT

[email protected]

8618790658707

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Official study title

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

Acronym: strabismus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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