Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oliceridine, Oxycodone.
- Who it may be relevant to
- Registry conditions: Vitrectomy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy: a Randomized Controlled Trial
Overview
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).
Interventions
- Drug Oliceridine
Intraoperative analgesia should be administered with Oliceridine - Drug Oxycodone
Oxycodone is used for intraoperative analgesia
Primary outcome measures
- VAS score 2 hours after operation [Time frame: From enrollment to the end of treatment at 1 day]
Secondary outcome measures (1)
- Adverse reactions [Time frame: From enrollment to the end of treatment at 1 day]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07097038 · HenanPPH-FNN2