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.

Study Overview

• Status: Not yet recruiting
• Conditions: Old Age
• Intervention / Treatment: Drug: Oliceridine; Drug: Sulfentanil

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ningning Fu; Phone Number: 8618790658707; Email: 736508728@qq.com
• Study Contact Backup: Name: Jiaqiang Zhang; Phone Number: 8613937121360; Email: Jiaqiang197628@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oliceridine group; 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; The formula for postoperative analgesia pump is oliceridine 0.4mg · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml.
Active Comparator: Sufentanil group; 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; The analgesic regimen for the sufentanil group is sufentanil 2 µ g · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions	Incidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia	48hour

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital
• Investigators: Study Director: Jiaqiang Zhang, Chief Physician

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pain; old age; knee arthroplasty
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Dsuvia; Sufentanil
• Other Study ID Numbers: HenanPPH-FNN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No