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NCT Number: NCT06668298

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>65 years old
  • ASA Level I-III
  • BMI 18.5-29.9
  • Patients undergoing knee joint surface replacement surgery under general anesthesia
  • Postoperative Patient Controlled Intravenous Analgesia Pump (PCIA) Treatment
  • Possess reading and writing abilities
  • You can sign an informed consent form

Exclusion criteria

  • 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
  • Abnormal liver and kidney function or dialysis patients
  • Concurrent severe cardiovascular, respiratory, and autonomic neuropathy
  • Participated in clinical studies of other drugs or medical devices in the past 3 months

Treatment and study plan

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.

Primary outcomes

  1. Measurement of Total Pain Intensity Difference within 48 Hours (SPID-48)

    Time frame: 48hour

    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.

Secondary outcomes

  1. Adverse reactions

    Time frame: 48hour

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaqiang Zhang

CONTACT

[email protected]

8613937121360

Ningning Fu

CONTACT

[email protected]

8618790658707

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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