An interventional study of Oliceridine and Sulfentanil in Old Age, sponsored by Henan Provincial People's Hospital. Not yet recruiting. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Henan Provincial People's Hospital · Not applicable, Interventional, and Prevention
Traditional opioid analgesia is a treatment method for moderate to severe pain. However, the use of opioid drugs is not without risks. When treating acute pain, patients may experience hypotension, respiratory depression, hypoxia, nausea and vomiting, irritability, and itching. The purpose of this study is to evaluate the comparison of G protein biased μ - opioid receptor agonist oliceridine and traditional μ - opioid receptor agonist sufentanil in terms of analgesia in patients under general anesthesia.
All patients who met the inclusion criteria were randomly divided into two groups based on the use of postoperative analgesic pumps: the sufentanil group and the oliceridine group. The sufentanil group received a treatment regimen of sufentanil 2 µ g · kg-1; The treatment regimen for the oliceridine group is oliceridine 0.4mg · kg-1. The main postoperative observation indicator is the measurement of total pain intensity difference within 48 hours (SPID-48).
Henan Provincial People's Hospital is the lead sponsor of 63 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Oliceridine 0.4mg · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml. PCIA is set to continuous infusion of 2ml/h, with a single dose of 2ml and a locking time of 15 minutes.
Drug: Oliceridine
Sufentanil 2 µ g · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml. PCIA is set to continuous infusion of 2ml/h, with a single dose of 2ml and a locking time of 15 minutes.
Drug: Sulfentanil
The formula for postoperative analgesia pump is oliceridine 0.4mg · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml.
The analgesic regimen for the sufentanil group is sufentanil 2 µ g · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml.
Measurement of Total Pain Intensity Difference within 48 Hours (SPID-48)
Postoperative pain was evaluated using the NRS Pain Digital Rating Scale at 1, 6, 12, 24, 36, and 48 hours post surgery; Multiply the difference in pain intensity at each post baseline time point within 48 hours (subtracting the pain intensity at a specific post baseline time point from the pain intensity at baseline) by the duration (in hours) of the previous time point, and then add them up.
Time frame: 48hour
Adverse reactions
Incidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia
Time frame: 48hour
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Henan Provincial People's Hospital