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临床试验/NCT07112157
NCT07112157尚未招募不适用

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

Henan Provincial People's Hospital0 个研究点目标入组 290 人开始时间: 2025年8月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
290
主要终点
Adequate rate of intraoperative analgesia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Oliceridine group

Experimental

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

干预措施: Oliceridine (Drug)

Sufentanil group

Active Comparator

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

干预措施: Sulfentanil (Drug)

结局指标

主要结局

Adequate rate of intraoperative analgesia

时间窗: 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).

Success rate of initial insertion of laryngeal mask

时间窗: 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)

次要结局

  • Ocular Heart Reflex (OCR) incidence rate(From enrollment to the end of treatment at 1 day)
  • Hemodynamic fluctuations(From enrollment to the end of treatment at 1 day)
  • Respiratory inhibition:(From enrollment to the end of treatment at 1 day)
  • Postoperative nausea and vomiting (PONV) (0-24h)(From enrollment to the end of treatment at 1 day)

研究者

申办方类型
Other
责任方
Sponsor

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