Preoperative dexamethasone palmitate to prevent postoperative nausea and vomiting after minimally invasive endoscopic surgery
Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Minimally Invasive Endoscopic Surgery
NA · Beijing Tiantan Hospital · NCT06981754
We will test whether giving dexamethasone palmitate before minimally invasive endoscopic surgery reduces postoperative nausea and vomiting in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 588 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06981754 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares preoperative dexamethasone palmitate with standard dexamethasone in adults undergoing elective minimally invasive endoscopic (laparoscopic or thoracoscopic) surgery under general anesthesia. Participants aged 18–65 who meet inclusion criteria will receive one of the study drugs before surgery and be followed for PONV outcomes and adverse events in the immediate postoperative period, with the primary outcome measured within 24 hours. The protocol excludes patients with recent systemic glucocorticoid use, severe organ disease, uncontrolled diabetes, pregnancy, or known allergy to dexamethasone. Safety and incidence of nausea and vomiting will be recorded to determine whether the palmitate formulation provides a longer antiemetic effect or fewer side effects than standard dexamethasone.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 scheduled for elective laparoscopic or thoracoscopic surgery under general anesthesia who can give informed consent and do not have recent systemic steroid use or severe comorbidities.
Not a fit: Patients with a dexamethasone allergy, recent systemic glucocorticoid use, uncontrolled diabetes, severe heart/liver/kidney disease, pregnancy, or breastfeeding are unlikely to participate or benefit.
Why it matters
Potential benefit: If successful, this could reduce the frequency and duration of postoperative nausea and vomiting using a longer-acting steroid with potentially fewer side effects.
How similar studies have performed: Dexamethasone is commonly used for PONV prevention and the palmitate formulation has shown longer anti-inflammatory effects in other settings, but clinical evidence specifically for PONV is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 to 65 years; * Providing written informed consent; * Patients scheduled to undergo elective minimally invasive endoscopic surgery (laparoscopic or thoracoscopic surgery) under general anaesthesia. 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, Beijing Municipality
- Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Fang Luo
- Email: 13611326978@163.com
- Phone: 59976661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Nausea and Vomiting, Dexamethasone Palmitate, Minimally Invasive Endoscopic Procedures