Dong-Xin Wang
Beijing, 100034, China
NCT Number: NCT06411665
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Beijing, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient-controlled intravenous analgesia with oliceridine for up to 3 days after surgery.
Other names: Oliceridine for injection
Patient-controlled intravenous analgesia with morphine for up to 3 days after surgery.
Other names: Morphine for injection
Time frame: Up to 72 hours after surgery.
Defined as the development of any nausea, retching, or vomiting within 72 h after surgery.
Time frame: Up to 72 hours after surgery
Defined as the development of any retching or vomiting within 72 h after surgery.
Time frame: Up to 72 hours after surgery
Nausea intensity is assessed with the numeric rating scale, an 11-point scale where 0=no nausea and 10=the most severe nausea.
Time frame: Up to 72 hours after surgery
Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain.
Time frame: Up to 72 hours after surgery
Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain.
Time frame: Up to 72 hours after surgery
Quality of recovery (QoR) is assessed with the QOR-15 scale, a 15-item scale that provides a global measure of postoperative recovery, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR).
Time frame: Up to 5 days after surgery.
Time to first flatus after surgery.
Time frame: Up to 5 days after surgery.
Time to first ambulation after surgery.
Time frame: At 72 hours after surgery.
Patients' satisfaction is assessed with a visual analogue scale, a 0-100 scale where 0=very dissatisfied and 100=very satisfied.
Time frame: Up to 72 hours after surgery.
Total opioid consumption within 72 hours after surgery.
Time frame: Up to 72 hours after surgery.
Subjective sleep quality is assessed with the numeric rating scale, an 11-point scale where 0=the best sleep and 10=the worst sleep.
Time frame: Up to 30 days after surgery.
Length of hospital stay after surgery.
Time frame: Up to 30 days after surgery.
Major complications are defined as new-onset medical events that are deemed harmful and required therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.
Peking University First Hospital
Other
Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting in Laparoscopic Colorectal Surgery: A Randomized Trial
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