NCT06411665

Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting

Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting in Laparoscopic Colorectal Surgery: A Randomized Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 14.4% of enrolled 106860 patients. The reported incidences in prospective studies varied between 25.5% to 33.3%. 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 0.35 mg or 0.5 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.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Oliceridine	Patient-controlled intravenous analgesia with oliceridine for up to 3 days after surgery.
DRUG	Morphine	Patient-controlled intravenous analgesia with morphine for up to 3 days after surgery.

Timeline

• Start date: 2024-07-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-05-13
• Last updated: 2024-10-08

Locations

1 site across 1 country: China