Strabismus SurgerystrabismusNCT07112157
Efficacy of Oxalidine and Sufentanil in Strabismus Correction
A study testing Oliceridine and Sulfentanil in people with Strabismus Surgery, run by Henan Provincial People's Hospital.
Trial 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. . Read more about this study
- Who is it for?
- Ages 3 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Strabismus Surgery
- What is being tested?
- Oliceridine and Sulfentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Oxalidine and Sufentanil in Strabismus Correction: a Non Inferiority 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.
Read the 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.
- Conditions
- Strabismus Surgery
- Being tested
- Oliceridine, Sulfentanil
- Keywords
- strabismus surgery, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
After entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction
SulfentanilDrug
After the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine group | Experimental | After entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction Receives: 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 Receives: Drug: Sulfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: From enrollment to the end of treatment at 1 day
Secondary outcomes (4)
Ocular Heart Reflex (OCR) incidence rate
HR decline>20% may require atropine intervention.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic fluctuations
Hypotension (MAP<65 mmHg or decrease from baseline>30%), hypertension (MAP>100 mmHg)
Measured: From enrollment to the end of treatment at 1 day
Respiratory inhibition:
SpO ₂<90% or ETCO ₂>50 mmHg
Measured: From enrollment to the end of treatment at 1 day
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)
Measured: From enrollment to the end of treatment at 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strabismus SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112157
- Sponsor's protocol ID
- HenanPPH-FNN3
- Acronym
- strabismus
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxalidine and Sufentanil in Strabismus Correction: a Non Inferiority Trial
- ClinicalTrials.gov ID
- NCT07112157
- Acronym / sponsor ID
- strabismus / HenanPPH-FNN3
- Conditions
- Strabismus Surgery
- Keywords
- strabismus surgery, analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oliceridine group | Experimental | Drug: OliceridineAfter entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction |
| Sufentanil group | Active comparator | Drug: SulfentanilAfter the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OliceridineAfter entering the room, the patient was intravenously injected with oselidine at a dose of 0.08mg/kg during anesthesia induction | Drug | Oliceridine group |
| SulfentanilAfter the patient entered the room, sufentanil was injected intravenously during anesthesia induction with a dose of 0.4 μ g/kg | Drug | Sufentanil group |
Primary outcome
Adequate rate of intraoperative analgesia
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).
Success rate of initial insertion of laryngeal mask
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)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Strabismus Surgery
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
Active, not recruiting
Effect of Different Drugs on Emergency Delirium in Preschool Age Patient
Emergence Delirium, Anesthesia
Recruiting
True Muscle Transplantation Surgery Versus Augmented Semi Hang Back Recession in Large Angle Exotropia: Evaluation of Efficacy and Lateral Gaze Incomitance
Large Angle Exotropia
Not yet recruitingObservational study
Japanese Strabismus Outcomes Assessment and Research Group Study
Strabismus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Oliceridine and Sulfentanil in people with Strabismus Surgery, run by Henan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ningning Fu (8618790658707, 736508728@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate rate of intraoperative analgesia (time frame: From enrollment to the end of treatment at 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.