Clinical trial NCT06411665: Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting
Official title: Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting in Laparoscopic Colorectal Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative nausea and vomiting
Laparoscopic colorectal surgery
Postoperative analgesia
Oliceridine
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 80 years;
2. Scheduled to undergo elective laparoscopic colorectal surgery;
3. Required patient-controlled intravenous analgesia.

Exclusion Criteria:

1. Pregnancy.
2. 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.
3. Unable to complete preoperative assessment due to severe dementia or language barrier.
4. Other conditions that are considered unsuitable for study participation.

Primary outcomes:
measure: The incidence of postoperative nause and vomiting (PONV) with 72 hours.
timeFrame: Up to 72 hours after surgery.
Secondary outcomes:
measure: The incidence of postoperative vomiting within 72 hours.
timeFrame: Up to 72 hours after surgery
measure: Area under curve of nausea intensity at predefined timepoints.
timeFrame: Up to 72 hours after surgery
measure: Area under curve of pain intensity at rest at predefined timepoints.
timeFrame: Up to 72 hours after surgery
measure: Area under curve of pain intensity with movement at predefined timepoints
timeFrame: Up to 72 hours after surgery
measure: Quality of recovery at 24 hours and 72 hours after surgery.
timeFrame: Up to 72 hours after surgery
measure: Time to first flatus after surgery.
timeFrame: Up to 5 days after surgery.
Other outcomes:
measure: Time to first ambulation after surgery.
timeFrame: Up to 5 days after surgery.
measure: Patients' satisfaction score with postoperative analgesia.
timeFrame: At 72 hours after surgery.
measure: Total opioid consumption within 72 hours after surgery.
timeFrame: Up to 72 hours after surgery.
measure: Subjective sleep quality during the first 3 nights after surgery.
timeFrame: Up to 72 hours after surgery.
measure: Length of hospital stay after surgery.
timeFrame: Up to 30 days after surgery.
measure: Major complications within 30 days after surgery.
timeFrame: Up to 30 days after surgery.
Locations:
city: Beijing
country: China
facility: Dong-Xin Wang
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, PHD
role: STUDY_DIRECTOR
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