Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy

NCT ID: NCT07097038

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-07-31

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).

Conditions

Vitrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Oliceridine group

Intraoperative analgesia: Oliceridine 0.015mg/kg

Group Type: EXPERIMENTAL

Oliceridine

Intervention Type: DRUG

Intraoperative analgesia should be administered with Oliceridine

Oxycodone group

Intraoperative analgesia oxycodone 0.04mg/kg

Group Type: ACTIVE_COMPARATOR

Oxycodone

Intervention Type: DRUG

Oxycodone is used for intraoperative analgesia

Interventions

Oliceridine

Intraoperative analgesia should be administered with Oliceridine

Intervention Type: DRUG

Oxycodone

Oxycodone is used for intraoperative analgesia

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ningning Fu

Role: CONTACT

736508728@qq.com

8618790658707

Other Identifiers

HenanPPH-FNN2

Identifier Type: -

Identifier Source: org_study_id