Efficacy of Oxalidine and Sufentanil in Strabismus Correction
ConditionStrabismus Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-60
SponsorHenan Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The patients to be treated with strabismus correction under general anesthesia are 3-60 years old, regardless of gender.
Disqualifiers
Those who are allergic to oxalidine, sufentanil or any of the ingredients in their preparations.
Trial design
Design model
Parallel
Treatments tested in this trial
Oliceridine
DrugAfter entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction
Sulfentanil
DrugAfter the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: Oliceridine groupExperimental treatment 1 intervention
Group B: Sufentanil groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adequate rate of intraoperative analgesia
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 day2
Success rate of initial insertion of laryngeal mask
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 daySecondary outcomes
1
Ocular Heart Reflex (OCR) incidence rate
HR decline\>20% may require atropine intervention.
Time frame
From enrollment to the end of treatment at 1 day2
Hemodynamic fluctuations
Hypotension (MAP\<65 mmHg or decrease from baseline\>30%), hypertension (MAP\>100 mmHg)
Time frame
From enrollment to the end of treatment at 1 day3
Respiratory inhibition:
SpO ₂\<90% or ETCO ₂\>50 mmHg
Time frame
From enrollment to the end of treatment at 1 day4
Postoperative nausea and vomiting (PONV) (0-24h)
Rating: 0=none; 1=Mild (no need for treatment); 2=Moderate (requires antiemetic medication); 3=Severe (repeated vomiting)
Time frame
From enrollment to the end of treatment at 1 dayLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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