Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530563
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery a Randomized Double-blind Positive-drug Parallel-controlled Multi-center Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if Oliceridine fumarate injection works to treat acute pain after abdominal surgery It will also learn about the safety of Oliceridine fumarate injection The main questions it aims to answer are
1 Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery
2 Does Oliceridine fumarate injection lead to less adverse effect
Researchers will compare Oliceridine fumarate injection to a positive-drug Sufentanil Citrate to see if Oliceridine fumarate injection not inferior to sufentanil in the efficacy and safety for acute pain after abdominal surgery
Participants will
1 Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery
2 Be followed up every 6 hours until 48 hours after surgery or before discharge
1 Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery
2 Does Oliceridine fumarate injection lead to less adverse effect
Researchers will compare Oliceridine fumarate injection to a positive-drug Sufentanil Citrate to see if Oliceridine fumarate injection not inferior to sufentanil in the efficacy and safety for acute pain after abdominal surgery
Participants will
1 Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery
2 Be followed up every 6 hours until 48 hours after surgery or before discharge
Detailed Description:
Traditional opioid such as morphine sufentanil is an important drug treatment of postoperative period of acute pain but their use is often limited because of significant side effects such as respiratory depression postoperative nausea and vomiting and sedation If a drug is effective treatment of postoperative pain and avoid these adverse reactions it will shorten the postoperative recovery time of patients increase patients satisfaction and reduce hospitalization costs Basic research shows that traditional opioids mainly bind to μ-opioid receptors and activate G protein signal transduction to exert analgesic effect In addition they stimulate the recruitment of β-arrestin leading to respiratory depression nausea and vomiting and other side effects Oliceridine is a newly μ-opioid receptor agonist which mainly activates the G protein signaling pathway to exert analgesic effect but has a weak recruitment effect on β-arrestin and thus reduces the incidence of adverse reactions However due to its recent introduction to the market there is still a lack of large-scale clinical studies on the application of Oliceridine in the population So this topic to discuss the analgesic efficacy and adverse reactions of Oliceridine in patients with acute pain after abdominal surgery Our study hypothesized that Oliceridine would have comparable analgesic efficacy and a lower incidence of associated side effects than sufentanil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None