Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Registration Number
- NCT06411665
- Lead Sponsor
- Peking University First Hospital
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 252
- Aged between 18 and 80 years;
- Scheduled to undergo elective laparoscopic colorectal surgery;
- Required patient-controlled intravenous analgesia.
- Pregnancy.
- Severe heart dysfunction (New York Heart Association functional classification 4), hepatic insufficiency (Child-Pugh grade C), renal insufficiency (serum creatinine of 442 μmol/L or above, or requirement of renal replacement therapy), or Amercian Society of Anesthesiologists classification IV or above.
- Unable to complete preoperative assessment due to severe dementia or language barrier.
- Other conditions that are considered unsuitable for study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oliceridine group Oliceridine Patient-controlled analgesia pump is provided immediately after surgery. The pump is established with oliceridine 15 mg, diluted with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a 10-min lockout interval and a background infusion rate at 1 ml/h. The pump will be used during the first 3 days after surgery. Morphine group Morphine Patient-controlled analgesia pump is provided immediately after surgery. The pump is established with morphine 50 mg, diluted with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a 10-min lockout interval and a background infusion rate at 1 ml/h. The pump will be used during the first 3 days after surgery.
- Primary Outcome Measures
Name Time Method The incidence of postoperative nause and vomiting (PONV) with 72 hours. Up to 72 hours after surgery. Defined as the development of any nausea, retching, or vomiting within 72 h after surgery.
- Secondary Outcome Measures
Name Time Method Quality of recovery at 24 hours and 72 hours after surgery. 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 to first flatus after surgery. Up to 5 days after surgery. Time to first flatus after surgery.
The incidence of postoperative vomiting within 72 hours. Up to 72 hours after surgery Defined as the development of any retching or vomiting within 72 h after surgery.
Area under curve of nausea intensity at predefined timepoints. 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.
Area under curve of pain intensity at rest at predefined timepoints. 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.
Area under curve of pain intensity with movement at predefined timepoints 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.
Trial Locations
- Locations (1)
Dong-Xin Wang
🇨🇳Beijing, China