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

Not Applicable

Not yet recruiting

• Conditions: Old Age
• Interventions: Drug: Oliceridine; Drug: Sulfentanil

• Registration Number: NCT06668298
• Lead Sponsor: Henan Provincial People's Hospital

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).

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• Study Start: 2024-11
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oliceridine group	Oliceridine	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.
Sufentanil group	Sulfentanil	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.

Primary Outcome Measures

Name	Time	Method
Measurement of Total Pain Intensity Difference within 48 Hours (SPID-48)	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 Outcome Measures

Name	Time	Method
Adverse reactions	48hour	Incidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia