Analgesic Effect and Safety of Oliceridine and Oxycodone in Vitrectomy
ConditionVitrectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Oliceridine
DrugIntraoperative analgesia should be administered with Oliceridine
Oxycodone
DrugOxycodone is used for intraoperative analgesia
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Oliceridine groupExperimental treatment 1 intervention
Group B: Oxycodone groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
VAS score 2 hours after operation
Postoperative 2-hour VAS score (total score of 10, 0 indicates no pain, and 10 indicates the most severe unbearable pain)
Time frame
From enrollment to the end of treatment at 1 daySecondary outcomes
1
Adverse reactions
ncidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia
Time frame
From enrollment to the end of treatment at 1 dayLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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