Clinical trial NCT06668298: Clinical Study of G Protein Biased Μ - Opioid Receptor Agonist Oliceridine for Optimizing Postoperative Analgesia Under General Anesthesia
Official title: Clinical Study of G Protein Biased Μ - Opioid Receptor Agonist Oliceridine for Optimizing Postoperative Analgesia Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Old Age
Keywords: old age
knee arthroplasty
pain
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of Total Pain Intensity Difference within 48 Hours (SPID-48)
timeFrame: 48hour
Secondary outcomes:
measure: Adverse reactions
timeFrame: 48hour
Other outcomes:
Locations:
Study officials:
affiliation: Chief physician
name: Jiaqiang Zhang
role: STUDY_DIRECTOR
References: