Preoperative dexamethasone palmitate to prevent nausea and vomiting after open surgery

Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Open Surgery

This tests whether giving a long-acting steroid called dexamethasone palmitate before open surgery can reduce postoperative nausea and vomiting in adults aged 18–65.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06997419 on ClinicalTrials.gov

What this trial studies

Dexamethasone palmitate is a long-acting formulation that may provide prolonged anti-inflammatory and antiemetic effects compared with standard dexamethasone. In this interventional comparison, adults undergoing elective open spinal, chest, or abdominal surgery under general anesthesia receive preoperative dexamethasone palmitate or standard dexamethasone and are followed for postoperative nausea and vomiting and safety outcomes. The protocol excludes patients with recent systemic glucocorticoid use, severe cardiac/hepatic/renal or systemic rheumatic disease, uncontrolled diabetes, active infection, cognitive impairment or severe mental illness, and pregnant or breastfeeding individuals. Outcomes include incidence of PONV in the early postoperative period (including within 24 hours) and adverse events related to steroid exposure.

Who should consider this trial

Good fit: Adults aged 18–65 undergoing elective open spinal, chest, or abdominal surgery under general anesthesia who can give informed consent and are not pregnant or breastfeeding.

Not a fit: People allergic to dexamethasone, those who used systemic glucocorticoids within three months, or those with uncontrolled diabetes, severe heart/liver/kidney disease, active infection, systemic rheumatic disease, or pregnancy/breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, it may offer longer-lasting prevention of postoperative nausea and vomiting with fewer side effects than standard dexamethasone.

How similar studies have performed: Standard dexamethasone is established to reduce PONV, but dexamethasone palmitate has been less studied for this indication and represents a relatively novel longer‑acting approach.

Eligibility criteria

Inclusion Criteria:

* Aged 18 to 65 years;
* Providing written informed consent;
* Perform elective open surgery (Spinal surgery, open chest surgery, open abdominal surgery) undergoing general anesthesia.

Exclusion Criteria:

* Known to be allergic to dexamethasone;
* Any systemic glucocorticoids within 3 months before trial entry;
* History of severe heart disease, liver/kidney failure, or systemic rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, et al);
* Cognitive impairment or severe mental illness;
* Uncontrolled diabetes or infectious diseases;
* Pregnancy or breastfeeding.

Where this trial is running

Beijing

• Fang Luo — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Postoperative Nausea and Vomiting; Dexamethasone Palmitate; Open Surgery