Vitrectomy
Conditions
Keywords
Basic anesthesia
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).
Interventions
DRUGOliceridine
Intraoperative analgesia should be administered with Oliceridine
DRUGOxycodone
Oxycodone is used for intraoperative analgesia
Sponsors
Henan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | From enrollment to the end of treatment at 1 day | ncidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia |
Contacts
Primary ContactNingning Fu
Outcome results
None listed