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Dexamethasone Palmitate for PONV After Minimally Invasive Endoscopic Surgery

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Capital Medical University

Status

Enrolling

Conditions

Postoperative Nausea and Vomiting
Minimally Invasive Endoscopic Procedures
Dexamethasone Palmitate

Treatments

Drug: Dexamethasone palmitate
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT06981754
KY2025-041-02-01

Details and patient eligibility

About

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, 14.0-26.3% of patients undergoing minimally invasive endoscopic procedures 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 surgery.

Enrollment

588 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

588 participants in 2 patient groups

Dexamethasone palmitate group
Experimental group
Treatment:
Drug: Dexamethasone palmitate
Dexamethasone group
Active Comparator group
Treatment:
Drug: Dexamethasone

Trial contacts and locations

1

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Central trial contact

Fang Luo

Data sourced from clinicaltrials.gov

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