Preoperative dexamethasone palmitate to prevent nausea and vomiting after craniotomy

Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Craniotomy

This will try whether a long-acting form of dexamethasone given before elective craniotomy reduces nausea and vomiting within 24 hours 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: NCT06988124 on ClinicalTrials.gov

What this trial studies

Dexamethasone palmitate, a lipid-formulated longer-acting corticosteroid, is being compared with standard dexamethasone given before elective craniotomy. Adult patients aged 18–65 undergoing general anesthesia will receive one of the two preoperative treatments and be followed for postoperative nausea and vomiting and adverse events. The main outcome is PONV within the first 24 hours after surgery, with additional data on rescue antiemetic use and safety. Patients with recent systemic steroids, severe organ dysfunction, uncontrolled diabetes, pregnancy or steroid allergy are excluded.

Who should consider this trial

Good fit: Adults 18–65 scheduled for elective craniotomy under general anesthesia who can give informed consent and do not have recent systemic glucocorticoid use or major contraindicating illnesses.

Not a fit: Patients with known dexamethasone allergy, recent systemic glucocorticoid use, uncontrolled diabetes, severe heart/liver/kidney disease, systemic rheumatic disease, pregnancy, breastfeeding, cognitive impairment, or severe mental illness are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could reduce early postoperative nausea and vomiting after craniotomy and provide longer-lasting antiemetic protection with fewer steroid-related side effects.

How similar studies have performed: Standard dexamethasone is commonly used and shows benefit for PONV prevention, but dexamethasone palmitate has limited published data in this surgical context and remains less tested.

Eligibility criteria

Inclusion Criteria:

* Aged 18 to 65 years;
* Providing written informed consent;
* Perform elective craniotomy 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