Clinical Study of G Protein Biased Μ - Opioid Receptor Agonist Oliceridine for Optimizing Postoperative Analgesia Under General Anesthesia

ConditionOld Age
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHenan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age>65 years old

ASA Level I-III

BMI 18.5-29.9

Patients undergoing knee joint surface replacement surgery under general anesthesia

Disqualifiers

Suffering from chronic pain or mental illness before surgery

Unable to communicate due to cognitive impairment or language barriers before surgery

Patients who have used opioid drugs three days before surgery

Patients with long-term alcohol consumption

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oliceridine

    Drug

    The formula for postoperative analgesia pump is oliceridine 0.4mg · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml.

  • Sulfentanil

    Drug

    The analgesic regimen for the sufentanil group is sufentanil 2 µ g · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Oliceridine groupExperimental treatment 1 intervention
Group B: Sufentanil groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Adverse reactions

Incidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia

Time frame
48hour

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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