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

Zhengzhou University

Status: Not yet enrolling

Conditions: Old Age

Treatments: Drug: Oliceridine; Drug: Sulfentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT06668298

HenanPPH-FNN

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 150 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Suffering from chronic pain or mental illness before surgery
2. Unable to communicate due to cognitive impairment or language barriers before surgery
3. Patients who have used opioid drugs three days before surgery
4. Patients with long-term alcohol consumption
5. Abnormal liver and kidney function or dialysis patients
6. Concurrent severe cardiovascular, respiratory, and autonomic neuropathy
7. Participated in clinical studies of other drugs or medical devices in the past 3 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Oliceridine group

Experimental group

Description:

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.

Treatment:

Drug: Oliceridine

Sufentanil group

Active Comparator group

Description:

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.

Treatment:

Drug: Sulfentanil