Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy

NCT07097038 — Not applicable, Not yet recruiting, 120 participants, Henan Provincial People's Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy: a Randomized Controlled Trial

Registry	NCT07097038
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	120 (Estimated)
Sponsor	Henan Provincial People's Hospital (Other)
Conditions	Vitrectomy
Interventions	Oliceridine, Oxycodone (Drug)
Dates	start 2025-07-01 (estimated), primary completion 2025-12-01 (estimated), completion 2026-07-01 (estimated), first posted 2025-07-31, last updated 2025-07-31

-Summary

Traditional opioid analgesia is a method to treat moderate to severe pain. However, the use of opioids is not without risks. When treating acute pain, patients may have hypotension, respiratory depression, hypoxia, nausea and vomiting, irritability and pruritus. The aim of this study was to evaluate the analgesic effect and safety of g-protein-biased μ - opioid receptor agonists Oliceridine and oxycodone in vitrectomy.

Expand all sections · Collapse all

+Detailed description

a total of 120 patients scheduled for vitrectomy were randomly divided into Oliceridine group (n = 60) and oxycodone group (n = 60). The main outcome measure was visual analogue scale (VAS) at 2 hours after operation, and the secondary outcome measures included intraoperative analgesic drug addition, VAS scores at 6 and 24 hours after operation, respiratory depression (oxygen saturation < 90%) and incidence of adverse reactions (nausea, vomiting, dizziness).

+Arms and interventions

Arm	Type	Interventions	Description
Oliceridine group	Experimental	Drug: Oliceridine	Intraoperative analgesia: Oliceridine 0.015mg/kg
Oxycodone group	Active comparator	Drug: Oxycodone	Intraoperative analgesia oxycodone 0.04mg/kg

Oliceridine (Drug): Intraoperative analgesia should be administered with Oliceridine
Oxycodone (Drug): Oxycodone is used for intraoperative analgesia

+Outcome measures

Primary outcomes

VAS score 2 hours after operation [From enrollment to the end of treatment at 1 day]: Postoperative 2-hour VAS score (total score of 10, 0 indicates no pain, and 10 indicates the most severe unbearable pain)

Secondary outcomes

Adverse reactions [From enrollment to the end of treatment at 1 day]: ncidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

Inclusion Criteria:

* Age 18-75 years old, ASA Ⅰ - Ⅱ (the age of patients with vitreous surgery can be relaxed to 75 years old, and serious systemic diseases need to be excluded);
* Vitrectomy with local anesthesia (retrobulbar / peribulbar block) combined with intravenous sedation and analgesia (such as maculopathy, retinal detachment, etc.);
* Preoperative VAS score ≤ 3, can cooperate with pain and sedation score;
* Signed informed consent.

Exclusion Criteria:

* Be allergic to test drugs or opioids, or have a history of opioid abuse;
* Severe cardiopulmonary disease (such as heart failure, COPD), liver and kidney dysfunction (alt/ast > 3 times normal, creatinine > 177 μ mol/l);
* Glaucoma (avoiding the risk of fluctuation of intraocular pressure), sinus bradycardia (< 50 beats / min, preventing aggravation of oculo cardiac reflex);
* Used analgesic / sedative drugs within 24 hours before surgery;
* Those who are unable to cooperate due to mental illness or cognitive impairment.