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The Effect of Oliceridine versus Hydromorphone on Gastrointestinal Tolerability in Patients Undergoing Major Abdominal Surgery with Multimodal Analgesia: A Prospective, Randomized Controlled Study

The Effect of Oliceridine versus Hydromorphone on Gastrointestinal Tolerability in Patients Undergoing Major Abdominal Surgery with Multimodal Analgesia: A Prospective, Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111214
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Acute postoperative pain

Interventions

Oliceridine group:After the procedure, administer 1.5 mg of Oxycodone, 0.2 mg/kg/72h Oxycodone, 10 mg of Tropisetron, diluted with 150 ml of normal saline, infused via intravenous analgesic pump at a
Hydromorphone group:After the procedure, administer 1 mg of hydromorphone, 0.1 mg/kg/72h hydromorphone, 10 mg of tropisetron, diluted with saline to 150 ml, and infused through an intravenous analgesi

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older; 2. ASA = 18 kg/m^2 and = 2 hours, hospitalization >= 3 days), including specific types of surgery such as colorectal, gastric, pancreatic, and complex gynecologic tumor surgeries planned via transfemoral TAVR approach; 5. Expected surgery duration >= 1 hour and <= 3 hours; 6. No need for other types of surgery; 7. Signed informed consent; 8. Able to understand the procedures and methods of this trial, willing to strictly comply with the clinical research protocol, and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Individuals with contraindications to anesthesia/sedation or a history of adverse reactions to anesthesia/sedation; 2. Those with known contraindications to opioids and their antagonists; 3. Excluding patients who have undergone nephrectomy, hepatectomy, emergency surgery, or minor laparoscopic procedures (e.g., laparoscopic cholecystectomy); 4. Severe liver dysfunction (Child-Pugh class C) or renal insufficiency (eGFR < 30 mL/min/1.73m^2); 5. History of severe nausea and vomiting, or gastrointestinal motility disorders such as gastroparesis; 6. Severe cardiopulmonary dysfunction or sleep apnea; 7. Shock during the screening period or hypotension that is difficult to correct with vasoactive drugs; 8. History of neurological or psychiatric disorders: traumatic brain injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; or schizophrenia, mania, long-term use of psychiatric medications, or cognitive impairment; 9. Patients planning postoperative ICU admission; 10. Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
The incidence of PONV within 72 hours postoperatively;

Secondary

MeasureTime frame
Severity of PONV;Incidence of PONV, time to first episode, and requirement for rescue antiemetics;Rate of gastrointestinal function recovery within 72 hours postoperatively (measured by GI-3 recovery);Time to GI-3 recovery, time to GI-2 recovery;Time to first flatus, time to first bowel movement, time to first oral intake of liquids;Incidence of postoperative ileus (defined as failure to achieve GI-3 by 120 hours postoperatively);Numeric Rating Scale Score;Frequency and dosage of rescue analgesics;Postoperative opioid consumption;Quality of Recovery-15 (QoR-15) score;Time to meet medically defined discharge criteria;Inflammatory markers (CRP, IL-6, TNF-a);Total length of hospital stay within 30 days postoperatively;Unplanned readmission within 30 days postoperatively;Major surgical complications (Clavien-Dindo classification = Grade 3);30-day and 90-day postoperative mortality rates;

Countries

China

Contacts

Public ContactMin Yan

The Second Affiliated Hospital, Zhejiang University School of Medicine

zryanmin@zju.edu.cn+86 135 8887 2603

Outcome results

None listed

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