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Comparison of Oliceridine and Hydromorphone for Nausea and Vomiting in Patient-Controlled Intravenous Analgesia After Orthopedic Surgery Under Multimodal Analgesia: A Prospective Cohort Study

Gastrointestinal Tolerability of the G Protein-Biased Agonist Oliceridine Versus Hydromorphone: A Prospective Cohort Study in Acute Postoperative Pain

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113933
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Interventions

Control group:After the surgery, 1 mg of hydromorphone and 10 mg of hydromorphone with 10 mg of tropisetron were administered, diluted with saline to 100 ml. The solution was infused through a intrave
Experimental group:After the procedure, administer 1mg of Oxycodone, 10mg of Oxycodone, and 10mg of Tropisetron, diluted in 100ml of saline. Infuse through a intravenous analgesic pump at a rate of 1m

Sponsors

The Second Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. Expected surgery duration >=1 and =18 and =18 and <=30 kg/m^2; 5. American Society of Anesthesiologists (ASA) physical status classification I–III; 6. No need to undergo other types of surgery; 7. Signed informed consent; 8. Patients scheduled for elective spinal surgery, total hip, or knee replacement surgery; 9. Ability to understand the procedures and methods of this trial, willingness to strictly follow the clinical study protocol, and voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. Individuals with contraindications to anesthesia/sedation or a history of adverse events related to anesthesia/sedation; 2. Individuals with known contraindications to opioids and their reversal agents; 3. During the screening period, those with shock or hypotension difficult to correct with vasoactive drugs, or with a history of adverse events; 4. Individuals with a history of neurological or psychiatric disorders: traumatic brain injury, convulsions, epilepsy, increased intracranial pressure, cerebral aneurysm, cerebrovascular disease, schizophrenia, mania, long-term use of psychiatric medications, cognitive impairment, etc.; 5. Hemoglobin (HB) < 10.0 g/dL (100 g/L) during the screening period; 6. Individuals with a history of long-term use of analgesics or sedatives, which the investigator deems unsuitable for participation in this study; 7. During the screening period, those with severe cardiac, pulmonary, hepatic, or renal diseases that investigators deem unsuitable for participation in this study; 8. Other conditions that the investigator considers unsuitable for participation in this trial; 9. Patients planned for postoperative ICU admission; 10. Pregnant or breastfeeding women; 11. Sleep apnea; 12. Preoperative gastrointestinal diseases (such as gastroesophageal reflux, irritable bowel syndrome, etc.).

Design outcomes

Primary

MeasureTime frame
The overall incidence of postoperative nausea and vomiting (PONV) within 48 hours after surgery.;

Secondary

MeasureTime frame
PONV severity;Incidence of PONV / Frequency of PONV episodes;Time to first PONV episode;Need for rescue antiemetics;Constipation, defined as no spontaneous bowel movement within 48 hours postoperatively.;Incidence of postoperative ileus;NRS score at 48 hours postoperatively;The frequency and dose of rescue analgesia;Drug consumption: the total drug consumption recorded by the PCIA pump within 42 hours.;Respiratory Depression;Oversedation;Pruritus;Length of Stay;Hospitalization Costs;Postoperative Complications;

Countries

China

Contacts

Public ContactMin Yan

The Second Affiliated Hospital, Zhejiang University School of Medicine

zryanmin@zju.edu.cn+86 571 7788 2883

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026