Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy

Zhengzhou University

Status: Not yet enrolling

Conditions: Vitrectomy

Treatments: Drug: Oxycodone; Drug: Oliceridine

Study type: Interventional

Funder types: Other

Identifiers

NCT07097038

HenanPPH-FNN2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Oliceridine group

Experimental group

Description:

Intraoperative analgesia: Oliceridine 0.015mg/kg

Treatment:

Drug: Oliceridine

Oxycodone group

Active Comparator group

Description:

Intraoperative analgesia oxycodone 0.04mg/kg

Treatment:

Drug: Oxycodone