Oliceridine
DrugAfter entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction
NCT Number: NCT07112157
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.
Trial opening soon.
Get Notified3 year–60 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
After entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction
After the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg
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).
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)
Time frame: From enrollment to the end of treatment at 1 day
HR decline>20% may require atropine intervention.
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)
Time frame: From enrollment to the end of treatment at 1 day
SpO ₂<90% or ETCO ₂>50 mmHg
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)
Contact information is provided by the study sponsor or research team.
Henan Provincial People's Hospital
Other
Efficacy of Oxalidine and Sufentanil in Strabismus Correction: a Non Inferiority Trial
Acronym: strabismus
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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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