Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411665
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-08
Brief Title:
Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting in Laparoscopic Colorectal Surgery A Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postoperative nausea and vomiting PONV is common after surgery and impede rapid recovery after surgery Patients who undergo laparoscopic colorectal surgery are more likely to develop PONV due to the pneumoperitoneum interruption of gastrointestinal system delay of oral feeding and nasogastric catheterization as well as postoperative opioid analgesic requirement to control acute pain Oliceridine is a novel selective μ-opioid agonist It stimulates G protein signalling but is markedly less potent than morphine for β-arrestin recruitment the latter contributes to opioid-related adverse events including PONV It is postulated that G protein-biased agonists may deliver effective analgesia with fewer opioid-related adverse events This randomized trial aimed to investigate whether oliceridine for patient-controlled analgesia can decrease the incidence of PONV in patients recovering from laparoscopic colorectal surgery
Detailed Description:
Postoperative nausea and vomiting PONV is a common adverse event after surgery A retrospective study found that PONV occurred in 144 of enrolled 106860 patients The reported incidences in prospective studies varied between 255 to 333 Certain types of laparoscopic surgery are associated with an increased risk of PONV including bariatric surgery gynecological surgery and cholecystectomy PONV can lead to dehydration and electrolyte imbalances delay early ambulation impede rapid recovery after surgery decrease patients satisfactory and potentially prolong hospital stay and increase cost
Opioids are commonly used during the perioperative period and are associated with increased PONV Conventional opioids such as morphine and sufentanil activate both the G protein and β-arrestin pathways the latter approach contributes to opioid-related PONV through multiple mechanisms such as enhanced vestibular sensitivity direct effects on the chemoreceptor trigger zone and delayed gastric emptying Oliceridine is a novel selective μ-opioid agonist It stimulates G protein signalling but is markedly less potent than morphine for β-arrestin recruitment It is therefore postulated that G protein-biased agonists may deliver effective analgesia with fewer opioid-related PONV
Previous studies in patients with moderate-to-severe pain following orthopaedic surgery-bunionectomy or plastic surgery-abdominoplasty showed that oliceridine provided an excellent analgesic efficacy compared with morphine and placebo The analgesic efficiency of 035 mg or 05 mg oliceridine was equal to 1 mg morphine However the rate of PONV was significantly lower in patients given oliceridine than in those given morphine Patients who undergo laparoscopic colorectal surgery are more likely to develop PONV due to the pneumoperitoneum interruption of gastrointestinal system delay of oral feeding and nasogastric catheterization as well as postoperative opioid analgesia to control pain Thus selective μ-opioid agonist might be more suitable for postoperative analgesia for these patients
This randomized trial aimed to investigate whether oliceridine compared with morphine for postoperative analgesia can decrease the incidence of PONV in patients after laparoscopic colorectal surgery
Opioids are commonly used during the perioperative period and are associated with increased PONV Conventional opioids such as morphine and sufentanil activate both the G protein and β-arrestin pathways the latter approach contributes to opioid-related PONV through multiple mechanisms such as enhanced vestibular sensitivity direct effects on the chemoreceptor trigger zone and delayed gastric emptying Oliceridine is a novel selective μ-opioid agonist It stimulates G protein signalling but is markedly less potent than morphine for β-arrestin recruitment It is therefore postulated that G protein-biased agonists may deliver effective analgesia with fewer opioid-related PONV
Previous studies in patients with moderate-to-severe pain following orthopaedic surgery-bunionectomy or plastic surgery-abdominoplasty showed that oliceridine provided an excellent analgesic efficacy compared with morphine and placebo The analgesic efficiency of 035 mg or 05 mg oliceridine was equal to 1 mg morphine However the rate of PONV was significantly lower in patients given oliceridine than in those given morphine Patients who undergo laparoscopic colorectal surgery are more likely to develop PONV due to the pneumoperitoneum interruption of gastrointestinal system delay of oral feeding and nasogastric catheterization as well as postoperative opioid analgesia to control pain Thus selective μ-opioid agonist might be more suitable for postoperative analgesia for these patients
This randomized trial aimed to investigate whether oliceridine compared with morphine for postoperative analgesia can decrease the incidence of PONV in patients after laparoscopic colorectal surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None