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

NCT06668298 | Not Yet Recruiting DMC

• 1 other identifier: HenanPPH-FNN
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Old Age

Keywords

old age; knee arthroplasty; pain

Outcome Measures

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.

  48hour

Secondary Outcomes (1)

• Adverse reactions

  48hour

Study Arms (2)

Oliceridine group

EXPERIMENTAL

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.

Drug: Oliceridine

Sufentanil group

ACTIVE COMPARATOR

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.

Drug: Sulfentanil

Interventions

Oliceridine DRUG

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

Oliceridine group

Sulfentanil DRUG

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

Sufentanil group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Conditions

Pain

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Sufentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jiaqiang Zhang

  Chief physician

  STUDY DIRECTOR

Central Study Contacts

Ningning Fu

CONTACT

8618790658707; 736508728@qq.com

Jiaqiang Zhang

CONTACT

8613937121360; Jiaqiang197628@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share