Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy

Not Applicable

Not yet recruiting

• Conditions: Vitrectomy
• Interventions: Drug: Oliceridine; Drug: Oxycodone

• Registration Number: NCT07097038
• Lead Sponsor: Henan Provincial People's Hospital

Brief 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.

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).

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2025-12
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oliceridine group	Oliceridine	Intraoperative analgesia: Oliceridine 0.015mg/kg
Oxycodone group	Oxycodone	Intraoperative analgesia oxycodone 0.04mg/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse reactions	From enrollment to the end of treatment at 1 day	ncidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia