Clinical trial NCT06997419: Dexamethasone Palmitate for PONV After Open Surgery
Official title: Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Open Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Dexamethasone Palmitate
Open Surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexamethasone is almost one of the most commonly used drugs for postoperative nausea and vomiting (PONV) prevention. However, PONV is still a complex problem to be solved; for example, even with preoperative dexamethasone administration, there are still some patients still experience PONV within 24 hours postoperatively. Compared to dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, 2-5 times that of traditional water-soluble dexamethasone, with fewer adverse effects. This trial aims to assess the effect and safety of preoperative dexamethasone palmitate on PONV after open surgery.


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.

Primary outcomes:
measure: The incidence of PONV
timeFrame: Within the first 24 hours postoperatively
Secondary outcomes:
measure: The Incidence of PONV
timeFrame: At 6 hours, 48 hours, and 72 hours postoperatively
measure: Incidence of postoperative nausea (PON) and postoperative vomiting (POV)
timeFrame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: The number of vomiting or retching episodes
timeFrame: Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: The severity of PONV
timeFrame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: Participant satisfaction with PONV management
timeFrame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: The use of rescue antiemetic drugs
timeFrame: During the 0-24 hours, 24-48 hours, and 48-72 hours postoperatively
measure: The quality of postoperative recovery (QoR)
timeFrame: At 24 and 48 hours postoperatively; At discharge; At 1 month postoperatively
measure: The VAS scale
timeFrame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: Postoperative length of stay (LOS)
timeFrame: Within one month after surgery
measure: Safety outcomes
timeFrame: Within one month after surgery
Other outcomes:
Locations:
Study officials:
References:
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