Postoperative Nausea and Vomiting
Conditions
Keywords
Postoperative nausea and vomiting, Laparoscopic colorectal surgery, Postoperative analgesia, Oliceridine
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.
Interventions
DRUGOliceridine
Patient-controlled intravenous analgesia with oliceridine for up to 3 days after surgery.
DRUGMorphine
Patient-controlled intravenous analgesia with morphine for up to 3 days after surgery.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients' satisfaction score with postoperative analgesia. | 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 to first ambulation after surgery. | Up to 5 days after surgery. | Time to first ambulation after surgery. |
| Subjective sleep quality during the first 3 nights after surgery. | 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. |
| Length of hospital stay after surgery. | Up to 30 days after surgery. | Length of hospital stay after surgery. |
| Major complications within 30 days after surgery. | 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. |
| Total opioid consumption within 72 hours after surgery. | Up to 72 hours after surgery. | Total opioid consumption within 72 hours after surgery. |
Countries
China
Contacts
Primary ContactXue Li, M.D.
Backup ContactDong-Xin Wang, M.D.
Outcome results
None listed