Efficacy of Oxalidine and Sufentanil in Strabismus Correction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oliceridine, Sulfentanil.
- Who it may be relevant to
- Registry conditions: Strabismus Surgery. Basic parameters: 3 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Oxalidine and Sufentanil in Strabismus Correction: a Non Inferiority Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- Adequate rate of intraoperative analgesia [Time frame: From enrollment to the end of treatment at 1 day]
- Success rate of initial insertion of laryngeal mask [Time frame: From enrollment to the end of treatment at 1 day]
Secondary outcome measures (4)
- Ocular Heart Reflex (OCR) incidence rate [Time frame: From enrollment to the end of treatment at 1 day]
- Hemodynamic fluctuations [Time frame: From enrollment to the end of treatment at 1 day]
- Respiratory inhibition: [Time frame: From enrollment to the end of treatment at 1 day]
- Postoperative nausea and vomiting (PONV) (0-24h) [Time frame: From enrollment to the end of treatment at 1 day]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07112157 · HenanPPH-FNN3