Efficacy of Oxalidine and Sufentanil in Strabismus Correction

NCT07112157 | Not Yet Recruiting DMC

• 1 other identifier: HenanPPH-FNN3
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Strabismus Surgery

Keywords

strabismus surgery; analgesia

Outcome Measures

Primary Outcomes (2)

• 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).

  From enrollment to the end of treatment at 1 day

• 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)

  From enrollment to the end of treatment at 1 day

Secondary Outcomes (4)

• 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

Study Arms (2)

Oliceridine group

EXPERIMENTAL

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

Drug: Oliceridine

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

Drug: Sulfentanil

Interventions

Oliceridine DRUG

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

Oliceridine group

Sulfentanil DRUG

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

Sufentanil group

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Conditions

Agnosia

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Sufentanil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ningning Fu

CONTACT

8618790658707; 736508728@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The purpose of this trial is to compare the analgesic effect of oxalidine and sufentanil in strabismus surgery, verify that the analgesic effect of oxalidine is not inferior to sufentanil, and evaluate the safety of the two drugs and the impact on postoperative recovery.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share